News

Barrx RF Ablation system success in Barrett's Oesophagus

Covieden has announced that results from a prospective, multicenter, randomized, controlled clinical trial (The SURF Trial -SUrveillance vs. RadioFrequency ablation)which showed that endoscopic ablation therapy using the Barrx RF Ablation System is effective at eliminating Barrett's Oesophagus, a pre-cancerous condition of the oesophagus, and preventing disease progression.

The authors reported that endoscopic ablation therapy resulted in a 94% relative ...

Inotuzumab ozogamicin (Pfizer) fails Phase III trial for NHL

Pfizer Inc. announced the discontinuation of a Phase III randomized, open-label, two-arm study (B1931008) evaluating the safety and efficacy of the investigational compound inotuzumab ozogamicin in patients with relapsed or refractory CD22+ aggressive non-Hodgkin Lymphoma (NHL) who are not candidates for intensive high-dose chemotherapy.

In this study, inotuzumab ozogamicin was administered on a once-a-month schedule in combination with rituximab and ...

Results positive for Afinitor (Novartis) in BOLERO-3 study in HER2 positive Breast Cancer

Results of a pivotal Phase III trial in women with HER2 positive (HER2+) advanced Breast Cancer showed that Afinitor (everolimus) tablets, from Novartis, in combination with Herceptin (trastuzumab) and vinorelbine significantly extended progression-free survival (PFS) after prior therapy when compared to treatment with placebo plus trastuzumab and vinorelbine, meeting the study's primary endpoint.

Efficacy and safety data from the ...

Phase III study of NEPA (Helsinn and Eisai) meets endpoint in patients with Nausea

Top-line results from a pivotal Phase III clinical study investigating NEPA (netupitant and palonosetron), from Helsinn and Eisai, for chemotherapy-induced Nausea and Vomiting (CINV), shows NEPA has superior complete response rates compared with palonosetron during the delayed phase after chemotherapy administration, which was the primary endpoint of the study. The global, randomized, double-blind, parallel group superiority study was designed to ...

Phase III study of Tomtovok (Boehringer) meets endpoint for NSCLC

The LUX-Lung 6 randomized, open-label Phase III trial comparing Tomtovok (afatinib), from Boehringer, to standard chemotherapy in 364 Asian patients with Non Small Cell Lung Cancer has met its primary endpoint. Within the study population, patients treated with afatinib (n=242) lived for a median of 11.0 months before their tumor started to grow again versus 5.6 months for patients treated ...

IDMC halts Phase III study of Vargatef (Boehringer) in NSCLC

The LUME-LUNG 2 double-blinded Phase III study evaluating Vargatef (nintedanib), from Boehringer, plus pemetrexed compared to pemetrexed plus placebo in patients with advanced non-squamous NSCLC has been halted at the recommendation of the Independent Data Monitoring Committee after 713 patients had been enrolled. This decision was based on the results of an interim review of efficacy (PFS) for a pre-defined ...

FDA approves Xofigo (Bayer HealthCare) for Prostate Cancer

The FDA has approved Xofigo (radium Ra 223 dichloride), from Bayer HealthCare, for the treatment of patients with castration-resistant Prostate Cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo (formerly Alpharadin) is the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival (OS) and delay in time to ...

Moxetumomab (MedImmune/AstraZeneca) moves into Phase III for Treatment of Hairy Cell Leukemia

MedImmune, AstraZeneca’s global biologics research and development arm, has enrolled the first patient in the Phase III clinical trial for moxetumomab pasudotox. The trial is sponsored by the Cancer Therapy Evaluation Program (CTEP), a programme within the Division of Cancer Treatment and Diagnosis at the US National Cancer Institute, and will evaluate moxetumomab pasudotox as a potential treatment in ...

GA 101 success in Phase III study for treatment of Chronic Lymphocytic Leukemia

The first results are announced by Genentech from CLL11, a Phase III study of the investigational medicine GA 101 (obinutuzumab) which is being conducted in collaboration with the German CLL Study Group (GCLLSG). The CLL11 study compared the combination of either GA 101 or Rituxan (rituximab) and chlorambucil, a standard chemotherapy, to chlorambucil alone in Chronic Lymphocytic Leukemia.

...

FDA approves Tarceva (Genentech/Astellas) for NSCLC as detected by cobas EGFR Mutation Test

Genentech, and Astellas Pharma US, Inc. have announced that the FDA has approved Tarceva (erlotinib) tablets for the initial (first-line) treatment of people with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR) activating mutations as detected by an FDA-approved test.

The FDA also approved the cobas EGFR Mutation Test, which was ...

Seattle Genetics files Adcetris at FDA for extended use in Hodgkin Lymphoma and sALCL

Seattle Genetics, Inc. has announced that the FDA has accepted for filing a supplement to the Biologics License Application (sBLA) supporting the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin Lymphoma (HL) and Systemic Anaplastic Large Cell Lymphoma (sALCL). The FDA is expected to take action on the application ...

Enzastaurin (Eli Lilly) fails Phase III trial for B Cell Lymphoma

Eli Lilly and Company has announced Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based ...

EU approves Octava Pink test (Eventus Diagnostics) for detecting Breast Cancer

The EU have awarded CE mark approval to the Octava Pink breast cancer test, from Eventus Diagnostics. The test is one of a new class of rapid, accurate and cost-effective blood tests that measure cancer-specific autoantibodies to detect the presence or absence of Breast Cancer. The Octava confirmatory tests are designed to be used in conjunction with annual screening mammograms. ...

ASPECCT study of Vectibix (Amgen) compared to Erbitux in treatment of Colorectal Cancer

Amgen announced that the Phase III head-to-head ASPECCT ('763) trial evaluating Vectibix (panitumumab) versus Erbitux (cetuximab) as a single agent for the treatment of chemorefractory metastatic Colorectal Cancer (mCRC) in patients with wild-type KRAS tumors (n=1,010) met its primary endpoint of non-inferiority for overall survival. The estimated overall survival hazard ratio (Vectibix/Erbitux) was 0.966 (95 percent CI: 0.839, 1.113) ...

FDA Advisory Committee rejects Melblez Kit (Delcath) for Ocular melanioma metastatic to the Liver

Delcath Systems, Inc. announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that benefits of treatment with Delcath's Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) for the treatment of patients with unresectable Ocular melanoma metastatic to the Liver do not outweigh the risks associated with ...

CHMP recommends Revlimid for treatment of Myelodysplastic Syndromes

The Committee for Medicinal Products for Human Use (CHMP) has recommended Revlimid (lenalidomide)from Celgene for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk Myelodysplastic Syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

CHMP recommends Erivedge (Roche) for treatment of Basal Cell Carcinoma

Roche has announced that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval of Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic Basal Cell Carcinoma, or locally advanced Basal Cell Carcinoma inappropriate for surgery or radiotherapy. Conditional approval would make Erivedge the first licensed treatment for patients in Europe with ...

CHMP recommends Xtandi (enzalutamide) as a treatment for Prostate Cancer

Astellas Pharma Europe Ltd., the European Headquarters of Astellas Pharma Inc. and Medivation, Inc.have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending European Commission approval for Xtandi (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant Prostate Cancer whose disease has progressed on or after docetaxel therapy.

Enzalutamide is ...

Picato(Leo Pharma) fails IQWiG assessment for Actinic Keratosis in Germany

In a preliminary assessment, the German Institute for Quality and Efficiency in Health Care ( IQWiG) has concluded that Leo Pharma's Picato gel (ingenol mebutate) for Actinic Keratosis, does not provide any added benefit over diclofenac/hyaluronic.

IQWiG commented that the drug manufacturer did not submit any relevant data: it did not cite any studies that directly compared ingenol ...

NICE rejects Pixuvri (Cell Therapeutics) for the treatment of Non-Hodgkin's Lymphoma

NICE has issued draft guidance not recommending the use of Pixuvri (pixantrone), from Cell Therapeutics, for an aggressive form of Non-Hodgkin's Lymphoma. The committee concluded there was insufficient evidence to show that the drug is more effective than current treatments and also found that it does not represent good value for money. According to NICE, the clinical trial evidence submitted ...

FDA approves Versa HD Radiation Therapy System (Elekta)

Elekta has received 510(k) clearance from the FDA for the Versa HD radiation therapy system for cancer treatment. Versa HD is an advanced linear accelerator system designed to improve patient care and treat a broader spectrum of cancers. The system is fully integrated with the Agility 160-leaf multileaf collimator (MLC), giving the Versa HD high-definition, high-speed beam shaping over a ...

Phase II data shows PCI 32765 (Pharmacyclics Inc.) provides sustained control in CLL patients

Results from a Phase II trial of PCI 32765 (ibrutinib), from Pharmacyclics Inc., demonstrates the drug offers rapid and sustained control as a monotherapy in untreated, relapsed and refractory Chronic Lymphocytic Leukemia (CLL) patients, irrespective of characteristics that predict poor outcomes to chemoimmunotherapy. It included an analysis of two CLL patient cohorts: the elderly, above 65 years of age, (n=24) ...

Roche Diagnostics launches Elecsys Calcitonin Thyroid Cancer test

Roche Diagnostics has announced the global launch (except US) of Elecsys Calcitonin, a new laboratory test for the diagnosis and lifelong monitoring of medullary thyroid cancer patients after thyroid surgery. Calcitonin is a specific tumour marker that can help healthcare professionals diagnose medullary thyroid carcinoma early, as elevated concentrations of calcitonin in the blood are associated with the onset ...

Lymphoseek (Navidea) success in Head and Neck cancer trial

Navidea Biopharmaceuticals, Inc. announced top-line results from the interim analysis of its Phase III clinical trial, NEO3-06, of Lymphoseek (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma. Results of the pre-planned interim analysis demonstrated that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes (SLNs) in subjects with squamous cell carcinoma ...

Phase III success for Cymbalta (Eli Lilly) for Peripheral Neuropathy

Daily Cymbalta( duloxetine) therapy from Eli Lilly, was effective and well-tolerated for the treatment of painful Chemotherapy-induced Peripheral Neuropathy (CIPN), according to a randomized, double-blind, placebo-controlled Phase III trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.

Patients were randomized to receive duloxetine followed by placebo (n=115) or placebo followed by duloxetine (n=116); initial crossover periods for ...

Elacyt (Clavis Pharma) fails Phase III trial for AML

Clavis Pharma announced results of the Phase III CLAVELA study investigating Elacyt (elacytarabine) in patients with relapsed or refractory Acute Myeloid Leukaemia (AML). The trial showed that there was no significant difference in overall survival between the two arms where patients were randomised to receive either elacytarabine or investigator's choice of treatment. Median survival in the elacytarabine arm was ...

FDA issues Complete Response Letter to AP Pharma relating to AP F 530 for CINV

AP PHarma as announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for its lead product candidate, APF 530, for the prevention of Chemotherapy-induced Nausea and Vomiting (CINV). The FDA has requested the refinement of a product quality analytical test method, and that certain deficiencies identified during facility pre-approval inspections ...

European Commission grants conditional marketing approval to Bosulif (Pfizer) for PH+CML

The European Commission (EC) has granted conditional marketing authorization for Bosulif (bosutinib) from Pfizer, in the European Union for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive Chronic Myelogenous Leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib ...

NICE rejects Xalkori (Pfizer) for treatment of Non Small Cell Lung Cancer

The National Institute for Health and Clinical Excellence (NICE) has issued new draft guidance in which it does not recommend Xalkori (crizotinib),the tyrosine kinase inhibitor from Pfizer. for use in previously treated anaplastic-lymphoma-kinase-(ALK) positive advanced Non-Small-Cell Lung Cancer (NSCLC), but has opened a public consultation on this preliminary decision. NICE did not view the drug as being cost effective. ...

CRLX 101 (Cerulean Pharma) fails in Phase II trial for NSCLC

A randomized Phase IIb study of CRLX 101, from Cerulean Pharma, in patients with advanced Non-Small Cell Lung Cancer (NSCLC) did not meet its primary efficacy endpoint, overall survival benefit. Patients in the trial had measureable disease, previously progressed through one or two different regimens of chemotherapy, and had evidence of disease progression prior to enrollment.

The study enrolled 157 ...

CHMP recomends Iclusig (Ariad Pharma) for CML and Ph+ALL

Ariad Pharmaceuticals, Inc. has announced that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the marketing authorization application for Iclusig (ponatinib) for two indications: • The treatment of adult patients with chronic phase, accelerated phase or blast phase Chronic Myeloid Leukaemia (CML) who are resistant to dasatinib or nilotinib; ...

Phase II trial of OHR/AVR118 (Ohr Pharmaceutical) shows some benefits for cancer patients with Cachexia

Results of a Phase II trial to evaluate the effects of OHR/AVR118, from Ohr Pharmaceutical, in advanced Cancer patients with Cachexia, show the drug offers some benefits. Eighteen patients, three with stage III and fifteen with stage IV cancers completed the treatment protocol. While the primary trial end point of weight gain was not achieved, at the completion of treatment, ...

Study shows Picato (Leo Pharma) provides sustained clearance of Actinic Keratosis at 12 months

Results of long-term clearance rates of Actinic Keratosis lesions after treatment with Picato (ingenol mebutate gel), from Leo Pharma, demonstrated that patients showing sustained complete clearance at 12 months, was 46 per cent (n=108) on the face and scalp and 44 per cent (n=76) on the trunk or extremities.

The secondary outcome showed that patients in the overall population experienced ...

NICE rejects Afinitor (Novartis) for HER-2 negative, hormone receptor-positive Breast Cancer

NICE(The National Institute of Health and Clinical Excellence)in a provisional draft guidance has rejected Afinitor ((everolimus) from Novartis, for the treatment of HER-2 negative, hormone receptor-positive Breast Cancer. Patients with this condition have an average of 18-36 months to live from diagnosis and Afinitor is the first treatment offering a positive effect on the condition that affects 30,000 women ...

Phase III success for talimogene laherparepvec (Amgen) in Melanoma

Amgen has announced top-line results from the Phase III trial in Melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV Melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).

The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or ...

Firmagon (Ferring)shows lower CV risks in treatment of Prostate Cancer

Data presented at the European Association of Urology 2013 annual meeting in Milan, indicate that the gonadotropin releasing hormone (GnRH) antagonist Firmagon (degarelix) from Ferring, may be associated with lower risk of a cardiovascular (CV) event or death compared to commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists.

These data are based on a pooled analysis of 2,328 ...

Orexo sells US rights to Abstral to Galena Biopharma

Orexo AB has announced that it sold Abstral (fentanyl) Sublingual Tablets in the United States to Galena Biopharma, Inc. Under the terms of the agreement, Galena Biopharma will pay Orexo US$10 million upfront and an additional US$5 million within the first twelve months after signing, plus low double digit royalties and milestone payments based on pre-specified sales levels.

Abstral ...

Enobosarm (GTx) is published in The Lancet Oncology

The Lancet Oncology, has published online ahead of its April print edition the results from the randomized, double-blind, placebo-controlled Phase II clinical trial of Enobosarm from GTx to assess its effects on Muscle Wasting and physical function in patients with cancer.

Enobosarm (GTx-024) is a selective androgen receptor modulator (SARM), a new class of non-steroidal, tissue-specific anabolic agents that ...

FDA approves Lymphoseek (Navidea Biopharma) for intraoperative Lymphatic Mapping

The FDA has approved on 13 March 2013, Lymphoseek (technetium Tc 99m tilmanocept) Injection, from Navidea Biopharmaceuticals , a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with Breast Cancer or Melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Lymphoseek is an imaging drug that helps locate lymph nodes; it is not ...

Phase III study of perifosine (Aeterna Zentaris )for Multiple Myeloma discontinued

Aeterna Zentaris Inc. has announced that an independent Data Safety Monitoring Board ("DSMB") has recommended discontinuing the ongoing Phase III study comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade) and dexamethasone in patients with relapsed or relapsed/refractory Multiple Myeloma. Based on the outcome of its pre planned interim analysis of efficacy and safety, ...

MRI-guided focal laser ablation system (Visualase) shows promise in patients with Prostate Cancer

A small Phase I trial of an MRI-guided focal laser ablation system, from Visualase, designed to treat the diseased portion of the Prostate in patients with Prostate Cancer, suggests the technique is safe and can be performed without the troubling complications associated with more aggressive therapies. This study enrolled nine men with biopsy-confirmed, low-risk Prostate Cancers with an MRI of ...

IQWiG finds no clear benefit of using PET/CT for patients with Bone or Soft Tissue Tumours

The German Institute for Quality and Efficiency in Health Care (IQWiG) has found no robust conclusions as to the benefits of using PET alone or in combination with CT for patients with Bone and Soft Tissue Tumours. IQWiG searched the international literature for studies that had examined the consequences of a diagnostic intervention using PET or PET/CT on health aspects ...

EMA approves Perjeta ( Roche) for treatment of metastatic Breast Cancer

Roche has announced that the European Medicines Agency (EMA) has approved Perjeta(pertuzumab) for patients with previously untreated HER2-positive metastatic Breast Cancer (mBC). Perjeta is approved in combination with Herceptin (trastuzumab) and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable Breast Cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

The ...

Results from Phase II study of CHR 2797 (Cell Therapeutics) for AML published in the Lancet Oncology

Results from the OPAL Phase II study of CHR 2797 (tosedostat), from Cell Therapeutics, in elderly patients with relapsed or refractory Acute Myeloid Leukemia (AML) have been published in the Lancet Oncology. Results were released in 2012. The trial showed that once-daily oral tosedostat resulted in a disease control rate of 51%. Subset analyses suggested the greatest benefit occurred in ...

Study suggests omega-3 fish oil can help protect against Skin Cancer

Researchers have carried out the first clinical trial to examine the impact of the fish oils on the skin immunity. Results of the study found that taking a regular dose of fish oils boosted skin immunity to sunlight. Specifically, it also reduced sunlight-induced suppression of the immune system, which affects the body’s ability to fight Skin Cancer and infection. Volunteers ...

FDA approves Stivarga (Bayer HealthCare) in patients with GIST

The FDA has approved Stivarga (regorafenib), from Bayer HealthCare, to treat patients with locally advanced, unresectable or metastatic Gastrointestinal Stromal Tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Approval is based on data from the pivotal Phase III GRID trial, which showed that Stivarga plus best supportive care (BSC) statistically significantly improved progression-free survival (PFS) ...

NICE rejects extended use of Alimta (Eli Lilly) in NSCLC

NICE (The National Institute of Health and Clinical Excellence) has not recommended Alimta (pemetrexed) from Eli Lilly for use as a maintenance treatment for Non-Small-Cell Lung Cancer (NSCLC) following induction therapy with pemetrexed and cisplatin in its preliminary guidance.

NICE had given its recommendation to the drug as a first line treatment option for NSCLC and as a maintenance ...

FDA approves Kadcyla (Genentech/Roche) for HER2-positive metastatic Breast Cancer patients

The FDA has approved Kadcyla (trastuzumab emtansine), from Genentech/Roche, for the treatment of people with HER2-positive metastatic Breast Cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. The approval is based on results from EMILIA, a Phase III randomized study comparing Kadcyla to lapatinib in combination with Xeloda (capecitabine) in 991 people with HER2-positive Breast ...

Positive topline results from study of VXM01 (Vaximm) for Pancreatic Cancer

Topline data from a randomized, placebo-controlled, double-blind Phase I/II dose escalation study of vaccine VXM01, from Vaximm, shows the treatment met all key endpoints and demonstrated safety and tolerability in patients with Pancreatic Cancer. In this study (VXM01-01-DE), 45 patients with inoperable pancreatic cancer received several doses of VXM01 in addition to standard-of-care treatment, or placebo. Results indicate that the ...

Further results from TIVO-1 study of tivozanib (Aveo Oncology/ Astellas) for Renal Cell Carcinoma treatment

AVEO Oncology and Astellas have reported final overall survival (OS) results from the comparative Phase III TIVO-1 trial with tivozanib in the treatment of advanced Renal Cell Carcinoma (RCC). The protocol-specified analysis showed that the median OS of 28.8 months (95% CI: 22.5-NA) for the oral VEGF inhibitor was less than the 29.3 months (95% CI: 29.3-NA) for Nexavar ...

Avastin (Roche) success in Cervical Cancer trial

The National Institutes of Health (Gynaecological Oncology Group) revealed data showing that Avastin (bevacizumab) from Genentech/Roche, produced a median survival benefit of 17 months in the GOC 240 trial in patients with Cervical Cancer, compared to 13.3 months in the chemotherapy arm of the trial.

Roche provided the drug but was not involved in the trial itself. Full data ...

Phase II study of AZD6244 (AstraZeneca) shows benefits for patients with Ovarian Cancer

A Phase II trial provides the first evidence that AZD6244 (selumetinib), from AstraZeneca, shows a relatively high response rate for patients with Ovarian Cancer. This clinical trial for low-grade serous Ovarian Cancer shows eight of 52 (15 percent) patients had a complete or objective partial response (tumor shrinkage) and 34 (65 percent) had no disease progression during the two-year study. ...

FDA grants accelerated approval to Pomalyst (Celgene) to treat Multiple Myeloma

The FDA on 8 February 2013, approved Pomalyst (pomalidomide), from Celgene, to treat patients with Multiple Myeloma whose disease progressed after being treated with other cancer drugs. Pomalyst is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including ...

GSK files at EMA trametinib (monotherapy) and in combination with dabrafenib for Metastatic Melanoma

GSK announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for trametinib (MEK) as monotherapy and in combination with dabrafenib (BRAF) for the treatment of adult patients with unresectable or Metastatic Melanoma with a BRAF V600 mutation. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted GSK’s request for accelerated assessment of ...

GSK initiates Phase III study of combination dabrafenib and trametinib for Melanoma

GlaxoSmithKline plc. announced the start of COMBI-AD, a Phase III study evaluating the combination of dabrafenib, its BRAF inhibitor and trametinib, its MEK inhibitor as adjuvant therapy for Melanoma. This global study will investigate whether combining the two investigational agents can delay or prevent the recurrence of melanoma (Relapse Free Survival) in patients with Stage IIIa, IIIb, or IIIc ...

Obinutuzumab (Genentech) success in Phase III trial for CLL

Genentech has announced positive results from Stage 1 of CLL11, a Phase III randomized study to investigate the efficacy and safety profile of the investigational medicine obinutuzumab (GA101) plus chlorambucil chemotherapy compared with chlorambucil alone in people with previously untreated Chronic Lymphocytic Leukemia (CLL). An improvement in progression-free survival (PFS) was achieved as GA101 plus chlorambucil significantly reduced the risk ...

ThermoDox (Celsion) fails Phase III trial for Liver Cancer

Celsion Corporation has announced that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with Hepatocellular Carcinoma (HCC), also known as Primary Liver Cancer. Specifically, Celsion has determined, after conferring with its independent Data Monitoring Committee (DMC) that the HEAT Study did not meet the goal of demonstrating ...

Positive results from Phase III trial of Avastin (Genentech/Roche) in elderly Colorectal Cancer patients

The results of the Phase III AVEX trial show that Avastin (bevacizumab), from Genentech/Roche, in combination with Xeloda (capecitabine) can significantly extend the time people aged over 70 live without their previously untreated advanced Bowel Cancer worsening - by 4 months - compared to Xeloda alone (median progression free survival of 9.1 months compared to 5.1 months respectively, HR =0 ...

Phase III study of Neulasta (Amgen) for Neutropenia in Colorectal Cancer meets primary endpoint

PAVES, a Phase III trial evaluating Neulasta (pegfilgrastim), from Amgen, in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for first-line treatment of metastatic Colorectal Cancer, has met its primary endpoint, with Neulasta significantly reducing the incidence of febrile Neutropenia. All patients received treatment with either FOLFOX or FOLFIRI plus bevacizumab and were randomized to receive either placebo or 6 ...

FDA approves Gleevec (Novartis) to treat Ph+ALL

The FDA on 25 January 2013 approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated. Children with Ph+ ALL have a genetic abnormality that causes proteins called tyrosine kinases ...

FDA approves Edge Radiosurgery Suite (Varian Medical Systems) for Radiation Therapy

The FDA has given 510(k) clearance for Varian Medical System's Edge Radiosurgery Suite, a new dedicated system for performing advanced Radiation Therapy using new real-time tumor tracking and motion management technologies. The system includes an integrated six degrees of freedom couch that provides the accuracy, precision, and flexibility needed to position patients. It also allows expanded use of fluoroscopy and ...

Results of REDUCE study show benefits from Avodart/Avolve (Glaxo Smith Kline) for Prostate Cancer Risk

New results from the four-year REDUCE clinical study evaluating Prostate Cancer Risk reduction in men taking Avodart/Avolve (dutasteride), from Glaxo Smith Kline, have been announced. REDUCE results showed that dutasteride decreased the risk of biopsy detectable Prostate Cancer by 22.8 percent compared to a placebo group, but concerns remained about the drug’s effectiveness. Nearly 2,800 men from the REDUCE study ...

Abraxane(Celgene) success in MPACT trial for combination treatment of Pancreatic Cancer

Celgene International Sàrl,has announced that its phase III clinical trial of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naïve patients with metastatic Pancreatic Cancer demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine alone [(median of 8.5 vs. 6.7 months) (HR 0.72, P=0.000015)].

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical ...

CHMP recommends bosutinib (Pfizer) for PH+CML

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the conditional marketing authorization of bosutinib from Pfizer, in the European Union (EU), for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive Chronic Myelogenous Leukemia (Ph+ CML) ...

NICE draft guidance recommends therapies for Prevention of Breast Cancer

NICE (The National Institute of Health and Clinical Excellence) has produced draft guidance on familial Breast Cancer, proposing the use, over five years, of hormonal therapies, tamoxifen or Evista (raloxifene), by post menopausal women at a high risk of Breast Cancer. Both drugs reduce the risk but they do come with side effects, and these carry a different weight when ...

European Commission extends Zytiga(Janssen Cilag) indication in Prostate Cancer

Janssen-Cilag has announced that the European Commission has approved an extension to the licence of Zytiga (abiraterone acetate), to include its use in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant Prostate Cancer (mCRPC) in men who have failed on androgen deprivation therapy in whom chemotherapy is not yet indicated. The oral, once-daily drug, with prednisone ...

Phase III trial of MORAb 003 (Morphotek/Eisai) for Ovarian Cancer fails to meet primary endpoint

Top-line results from a Phase III study of MORAb 003 (farletuzumab), from Morphotek/Eisai, in combination with carboplatin and a taxane in patients with platinum-sensitive epithelial Ovarian Cancer in first relapse did not meet the study's primary endpoint of progression-free survival (PFS). In the double-blind, placebo-controlled FAR 131 study, 1,100 patients were enrolled to receive standard-of-care (carboplatin and a taxane [paclitaxel ...

Nexavar (Bayer) success in Phase III trial for Thyroid Cancer

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced that a Phase III trial of Nexavar (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated Thyroid Cancer has met its primary endpoint of a statistically significant improvement in progression-free survival. The study, called DECISION, evaluated the efficacy and safety of Nexavar compared to placebo. The safety and ...

IQWiG review of Inlyta(Pfizer),Nexavar (Bayer)and Afinitor (Novartis) as treatments for Renal Cell Carcinoma

IQWiG, the German drug assessment agency,recommended that Inlyta (axitinib) from Pfizer offered considerable additional benefit in the treatment of Renal Cell Carcinoma compared to Nexavar(sorafenib) from Bayer HealthCare. However it also found that Inlyta gave no additional benefit over Afinitor (everolimus) from Novartis.

Data supporting Inlyta over Nexavar came from the AXIS study. IQWiG found no difference in ...

AEZS-108 to commence Phase III trial for Endometrial Cancer

The FDA has approved an upcoming Phase III registration trial in Endometrial Cancer for AEZS-108 from Aeterna Zentaris Inc. This will be an open-label, randomized, multicenter Phase III trial conducted in North America and Europe, comparing AEZS-108 with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic Endometrial Cancer. The trial will involve approximately 500 patients and the ...

Navidea Biopharma files Lymphoseek at EMA for Intraoperative Lymphatic Mapping

Navidea Biopharmaceuticals, Inc. a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, has announced that it has submitted a Marketing Authorization Application for its investigational radiopharmaceutical Lymphoseek (technetium Tc 99m tilmanocept) injection, a novel intraoperative lymphatic mapping agent, to the European Medicines Agency. Lymphoseek is used in intraoperative lymphatic mapping , a surgical oncology procedure used primarily in patients with ...

Phase III trial of Stimuvax (Merck Serono) fails to meet primary endpoint in patients with NSCLC

The Phase III START study, a trial of L-BLP25 (formerly called Stimuvax), from Merck Serono, in patients with unresectable, locally advanced stage IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC) failed to meet its primary endpoint of demonstrating a statistically significant improvement in overall survival. No new or unexpected safety concerns were noted for the study. In prior clinical studies, ...

NICE does not recommend Avastin (Roche) as a treatment for Ovarian Cancer

The National Institute for Health and Clinical Excellence (NICE) has published draft guidance on the use of Avastin(bevacizumab) from Roche, as a treatment for women with advanced Ovarian Cancer. The draft guidance does not recommend the use of bevacizumab when used with paclitaxel and carboplatin for people with advanced disease, as a cost-effective treatment for the National Health Service....

CHMP recommends Perjeta (Genentech/Roche) for HER2+ Breast Cancer

The CHMP has given a positive opinion for the use of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel in patients with HER2-positive metastatic or locally recurrent unresectable Breast Cancer (mBC). The recommendation supports an indication for people with this specific type of cancer who have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease. The CHMP ...

BayerHealthCare submits Alpharadin to FDA for treatment of castration-resistant Prostate Cancer

Bayer HealthCare has submitted a New Drug Application to the FDA seeking approval for Alpharadin (radium-223 dichloride (radium-223)) for the treatment of castration-resistant Prostate Cancer in patients with bone metastases. The treatment has been granted fast track designation by the FDA.

The submission was based on data from the ALSYMPCA trial, a Phase III, randomized, double-blind, placebo-controlled international study ...

Positive results in Phase II study of BI 6727 (Boehringer) in patients with AML

Phase II results from an interim analysis of a study involving BI 6727 (volasertib), from Boehringer, in newly diagnosed patients with Acute Myeloid Leukemia (AML) shows higher rates of objective response and an improvement in event free survival in patients treated with volasertib in combination with low-dose cytarabine (LDAC), compared to patients treated with LDAC alone. Objective responses were observed ...

BOLERO-2 18-month follow-up shows benefits with Afinitor/Aromasin combination (Novartis/Pfizer) in Breast Cancer patients

Results from the Phase III BOLERO-2 trial show that the effects on survival observed with the Novartis drug Afinitor (everolimus) plus Aromasin (exemestane), from Pfizer, in women with Breast Cancer is maintained after 18 months. The trial studied the efficacy and safety of the two drugs versus placebo plus exemestane, in postmenopausal women with hormone receptor-positive advanced Breast Cancer that ...

BayerHealthCare submits Alpharadin to EMA for treatment of castration-resistant Prostate Cancer

Algeta ASA announces that Bayer HealthCare has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Alpharadin (radium-223 dichloride (radium-223)) for the treatment of castration-resistant Prostate Cancer in patients with bone metastases.

The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. ...

Phase II study success of quizartinib (Astellas/Ambit Bioscience) in AML

Astellas Pharma Inc. and Ambit Biosciences Corporation announced the results from a completed Phase II study with the investigational FLT3 inhibitor, quizartinib (AC220), as an oral monotherapy treatment regimen in patients with relapsed or refractory Acute Myeloid Leukemia (AML). Data from two study cohorts (patients aged ? 60 years with AML relapsed in <1 year or refractory to 1st-line chemotherapy; ...

NICE recommends Yervoy (BMS) and Zelboraf (Roche) for Melanoma

NICE, The National Institute of Health and Clinical Excellence, has provided final and binding guidance that recommends both Yervoy (ipilimumab) from BMS and Zelboraf (vemurafenib) from Roche, for melanoma patients. Both recommendations were conditioned on a discount offered under a patient access scheme. Yervoy is recommended for the treatment of advanced Malignant Melanoma in people who have received prior ...

Phase II study of PCI 32765 (Pharmacyclics Inc) shows some benefits in patients with Mantle Cell Lymphoma

Findings from an ongoing, open-label, Phase II, single-agent study shows that in patients with relapsed or refractory Mantle Cell Lymphoma (MCL), PCI 32765 (ibrutinib), from Pharmacyclics Inc., resulted in an overall response rate of 68 percent, including a complete response of 22 percent and a partial response of 46 percent. The study included both bortezomib-naive and bortezomib-exposed patients; 111 received ...

FDA expands Zytiga (Janssen Biotech) indication in Prostate Cancer

The FDA has expanded the approved use of Zytiga (abiraterone acetate) from Janssen Biotech, to treat men with late-stage (metastatic) castration-resistant Prostate Cancer prior to receiving chemotherapy. The FDA initially approved Zytiga in April 2011 for use in patients whose Prostate Cancer progressed after treatment with docetaxel, a chemotherapy drug. Zytiga is a pill that decreases the production of male ...

Two Phase III trials show benefits of Tasigna (Novartis) for patients with Ph+ CML

New results from two Phase III clinical trials further establish the benefits of Tasigna (nilotinib), from Novartis, compared to Gleevec (imatinib mesylate) in the treatment of Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) in newly diagnosed patients and in those with residual disease who switched to Tasigna after long-term treatment with Gleevec. Two-year results from ENESTcmr showed that switching to ...

Phase III trial success for PCI 32765 (Janssen Biotech) in CLL treatment

Research demonstrates that PCI 32765 (ibrutinib) from Pharmacyclics/Janssen Biotech, may be an effective and safe targeted treatment option for previously untreated, hard-to-treat, and relapsed patients with Chronic Lymphocytic Leukemia (CLL).

A study enrolled 116 CLL patient participants in several treatment cohorts: patients who were never treated (the treatment-naive group), those who had received two or more prior therapies ...

Roche submits extension application to EMA for subcutaneous MabThera

Roche has submitted a line extension application to the European Medicines Agency for a subcutaneous (SC) formulation of MabThera (rituxumab) for patients with Non-Hodgkin Lymphoma. Currently, MabThera is available as an IV formulation. The application is backed by pivotal study data which showed that SC administration of MabThera enabled the delivery of MabThera over approximately five minutes without compromising its ...

NICE rejects Inlyta(Pfizer) for treatment of Renal Cell Carcinoma

NICE, the healthcare guidance body, has issued draft guidance not recommending Inlyta (axitinib) from Pfizer, for the treatment of advanced Kidney Cancer.The preliminary decision by the independent Appraisal Committee is that axitinib should not be recommended for the treatment of advanced Renal Cell Carcinoma after failure of prior treatment with sunitinib or a cytokine. The trial data included a ...

Updated survival results from CLEOPATRA Phase III trial for Perjeta(Genentech) in Breast Cancer treatment

Genentech,/Roche), announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy significantly extended the lives (overall survival) of people with previously untreated HER2-positive metastatic breast cancer (mBC), compared to Herceptin, chemotherapy and placebo.

Results showed that the risk of death was reduced by 34 percent for ...

Phase II study of XL 184 (Exelixis) shows significant improvement in patients with castration-resistant Prostate Cancer

About two-thirds of patients with castration-resistant Prostate Cancer treated with XL 184 (cabozantinib), from Exelixis, had improvements on their bone scans, with 12 percent seeing complete resolution of uptake on bone scan, according to results of a Phase II study. The trial enrolled 171 men with castration-resistant Prostate Cancer, and began as a randomized trial in which all patients received ...

Rencarex (WILEX) programme in Renal Cell Carcinoma is cancelled

WILEX AG has agreed a package of restructuring measures with the company's Supervisory Board. The Executive Management Board is reacting to the results of the Phase III ARISER study with Rencarex which missed the primary endpoint. The measures are designed to tailor development activities to the remaining projects, reduce the risks inherent in the business model and lower operating ...

Orphan Europe acquires European rights to GRASPA for ALL

Recordati announces that its subsidiary Orphan Europe and Erytech Pharma, a late development stage French biopharmaceutical company focused on orphan oncology and rare diseases, have entered into an agreement granting Orphan Europe the exclusive rights for the commercialization and distribution of Graspa for the treatment of Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) in Europe. Graspa, (human erythrocytes ...

New Phase II trial shows combination treatment with selumetinib (AstraZeneca) has promise for patients with NSCLC

A new Phase II study finds that the combination of selumetinib, from AstraZeneca, and docetaxel, was more effective than docetaxel chemotherapy alone for patients with a form of Non-Small Cell Lung Cancer (NSCLC) that carries a mutation in the gene KRAS - representing about 20 percent of all NSCLC cases. Previously, no targeted agent had proven beneficial in a trial ...

FDA approves Cometriq (Exelixis Inc.) for treatment of Thyroid Cancer

The FDA on 29 November 2012 approved Cometriq (cabozantinib),formerly XL 184, from Exelixis Inc., to treat medullary Thyroid Cancer that has spread to other parts of the body (metastasized).

Cometriq is the second drug, with Caprelsa approved in April 2011 ,to treat medullary Thyroid Cancer in the past two years. The drug extended progression free survival for patients in a ...

Phase III trial of Stivarga (Bayer HealthCare) finds positive effect in patients with GIST

A new study demonstrates that Stivarga (regorafenib), from Bayer HealthCare, was able to control GIST for nearly four months longer than placebo in patients for whom Gleevec and Sutent were no longer effective, a result that was highly significant statistically. The Phase III international trial involved 199 treatment-resistant GIST patients at 57 hospitals in 176 countries. Of the 199 patients, ...

FDA approves 3D X- Ray for Breast Cancer

The FDA has approved the Selenia Dimensions System,from Hologic Inc., the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis. A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about ...

Abraxane (Celgene) success in Phase III study of Pancreatic Cancer

In a Phase III study,(the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound),from Celgene, in combination with gemcitabine in treatment-naïve patients with advanced Pancreatic Cancer met its primary endpoint of overall survival. In the study, Abraxane in combination with gemcitabine demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine ...

NICE rejects again Javlor (Pierre Fabre) as a treatment for Bladder Cancer

NICE (National Institute of Heatlth and Clinical Excellence) has rejected again the application from Pierre Fabre for Javlor (vinflunine) as a treatment for Bladder Cancer after platinum treatment has failed. NICE considered that there was insufficient evidence of clinical effectiveness compared to best supportive care. The 302 trial evidence could not be generalised to the entire UK population. There was ...

FDA approves Signifor (Novartis) for treatment of Cushing's Disease

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted unanimously in support of the use of Signifor (pasireotide) from Novartis, for the treatment of patients with Cushing's Disease who require medical therapeutic intervention. The recommendation was based on data from clinical trials of pasireotide, including PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease), the largest randomized Phase III study ...

T-DM1 (Genentech) is filed at FDA for HER-2 positive metastatic Breast Cancer

Genentech/Roche has announced that the FDA has accepted the company's Biologics License Application (BLA) for trastuzumab emtansine (T-DM1) and granted Priority Review. Trastuzumab emtansine’s proposed indication is for the treatment of people with HER2-positive, unresectable locally advanced or metastatic Breast Cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. The FDA confirmed the action date ...

Phase III trial of Urocidin (Endo Pharma) for Bladder Cancer is abandoned

A Phase III clinical trial with Urocidin (mycobacterial cell wall DNA complex), from Endo Pharma, in non-muscle-invasive Bladder Cancer is being discontinued. The trial, a randomized, active-controlled, open-label, multi-center study with a blinded endpoint assessment designed to compare Urocidin with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive Bladder Cancer, was being run by ...

EU approves Votubia (Novartis)for Renal Angiomyolipoma

Novartis received approval from the European Commission (EC) for Votubia (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or bilateral tumors) but who do not require immediate surgery. This ...

Study analyses role of Avastin (Roche/Genentech) in Colorectal Cancer

A recent paper that analysed the E2300 registration study of Avastin( bevacizumab) from Roche/Genentech, for Colorectal Cancer shows why Avastin has such an unpredictable effect. At least half of colorectal cancer patients, according to the study, who are given the drug derive no benefit. Patients with low levels of the VEGF 165b variant demonstrate both progression free survival and ...

FDA grants accelerated approval for Synribo ( Cephalon/Teva) for CML

The FDA on 26 October 2012 granted accelerated approval for Synribo (omacetaxine mepesuccinate)from Cephalon/Teva to treat adults with Chronic Myelogenous Leukemia (CML), a blood and bone marrow disease.

The drug’s effectiveness in chronic phase CML was demonstrated by a reduction in the percentage of cells expressing the Philadelphia chromosome genetic mutation found in most CML patients. Fourteen out of ...

Updated results in Phase III trial of Abraxane (Celgene Oncology) for patients with Metastatic Melanoma

New results from the CA 033 Phase III trial of Abraxane (nab-paclitaxel), from Celgene Oncology, show a statistically significant improvement in progression-free survival in chemotherapy-naïve patients with Metastatic Melanoma compared to patients receiving dacarbazine chemotherapy (4.8 vs. 2.5 months, respectively (HR:0.792; 95.1% CI: 0.631, 0.992; P=0.044). An interim analysis of overall survival, the secondary endpoint, shows a trend in favour ...

Xalkori (Pfizer) is EU approved conditionally for Non Small Cell Lung Cancer

Pfizer Inc. announced that the European Commission on 23 October 2012 has given conditional marketing authorization for Xalkori (crizotinib) in the European Union (EU) for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Similar to accelerated approvals in the United States, conditional marketing authorizations in the EU are ...

FDA approve ExAblate (InsighTec) to treat Pain from Bone Metastases

The FDA has approved ExAblate MRI-guided focused ultrasound, from InsighTec, as a therapy to treat Pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. The ExAblate system integrates magnetic resonance imaging and high intensity focused ultrasound. FDA approval was based on the results of an international, multi-center, randomized clinical study comparing ...

Successsful Phase III study of Actimid in Multiple Myeloma

A phase III, multi-center, randomized, open-label study (MM-003) of Actimid (pomalidomide) plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory Multiple Myeloma was reviewed by a data safety monitoring board (DSMB). The DSMB determined MM-003 met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis. Additionally, at the OS interim ...

FDA extend approval of Alimta (Eli Lilly) for maintenance treatment in NSCLC

The FDA has announced that patients may receive Alimta (pemetrexed for injection), from Eli Lilly, as a maintenance therapy following first-line Alimta plus cisplatin for locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NS NSCLC). The FDA approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these ...

Inlyta (Pfizer) not superior to Nexavar in Renal Cell Carcinoma trial

A Phase III study AGILE 1051, of Inlyta (axitinib) from Pfizer, did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS), versus Nexavar (sorafenib), in treatment-naïve patients with advanced Renal Cell Carcinoma (RCC).

A preliminary review of the data showed that overall the median PFS for Inlyta exceeded the median PFS for sorafenib, ...

Ramucirumab (Eli LillY) success iN Phase III trial for Gastric Cancer

The REGARD trial, a Phase III study of ramucirumab (IMC-1121B) from Eli Lilly, in patients with metastatic Gastric Cancer, met its primary endpoint of improved overall survival and also showed prolonged progression-free survival. This trial is the first Phase III data read-out for ramucirumab. The REGARD trial compared ramucirumab and best supportive care to placebo and best supportive care as ...

FDA approves Abraxane (Celgene Oncology) for NSCLC

The FDA has on 11 October 2012 approved Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) from Celgene Oncology, for the first-line treatment of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

The Abraxane sNDA approval is based upon the results ...

Abraxane (Celgene Oncology) success in Phase II study for Metastatic Melanoma

A Phase III, randomized, international study (CA033) reported for Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), from Celgene Oncology, in chemotherapy-naïve patients with Metastatic Melanoma. In the study, the primary endpoint was met with patients receiving Abraxane demonstrating a statistically significant improvement in progression-free survival compared to patients receiving dacarbazine (DTIC) chemotherapy. The safety profile of Abraxane observed in ...

ARQ 197 Phase III trial MARQUEE for NSCLC is stopped

ArQule, Inc. and Daiichi Sankyo, Co., Ltd. have announced that the independent Data Monitoring Committee (DMC) of the Phase III MARQUEE (Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC) trial recommended the study be stopped early following a planned interim analysis, when they concluded that the study would not meet its primary endpoint of improved overall ...

Updated survival results of EMILIA study for T-DM1 for metastatic Breast Cancer

Genentech has announced updated survival results from the Phase III EMILIA study, which showed that people with previously treated HER2-positive metastatic Breast Cancer (mBC) survived significantly longer (overall survival, a co-primary endpoint) when treated with trastuzumab emtansine (T-DM1) compared to those who received the combination of lapatinib and Xeloda (capecitabine). Results showed the risk of death was reduced by 32 ...

Positive results for Xalkori (Pfizer) in treatment of patients with ALK-positive Lung Cancer

The results of a new phase III trial show that Xalkori (crizotinib), from Pfizer, is a more effective treatment than standard chemotherapy for patients with advanced, ALK-positive Lung Cancer. The current global randomized phase III study compared the efficacy and safety of crizotinib with standard chemotherapy with pemetrexed or docetaxel, in 347 patients with ALK-positive lung cancer who had already ...

Votrient (GSK) is non inferior to Sutent ( Pfizer) in COMPRAZ study for Renal Cell Carcinoma

GSK announced that the pivotal Phase III study COMPARZ has met its primary endpoint. In the open-label, head-to-head study, Votrient (pazopanib) from GSK demonstrated non-inferiority to Sutent (sunitinib) from Pfizer in terms of progression free survival. Patients in the study were treated for advanced Renal Cell Carcinoma (mRCC) with a component of clear cell histology and had received no prior ...

EU approves subcutaneous Velcade (Janssen) for treatment of Multiple Myeloma

The EC has approved the subcutaneous version of Velcade (bortezomib) from J&J Janssen Cilag for Multiple Myeloma. Subcutaneous bortezomib has fewer side effects and offers greater convenience for patients, with similar efficacy compared to intravenous bortezomib....

Aveo files tivozanib at FDA for treatment of Renal Cell Carcinoma

AVEO Oncology and Astellas Pharma Inc. have announced that Aveo has submitted a New Drug Application (NDA) to the FDA seeking approval for tivozanib in patients with advanced Renal Cell Carcinoma (RCC). Tivozanib is designed to target the vascular endothelial growth factor (VEGF) pathway, a clinically validated target in RCC and other solid tumors. The NDA submission is based on ...

New quality-of-life data presented for Tomtovok (Boehringer) treated patients with NSCLC

Boehringer has released new results on the secondary endpoints of LUX-Lung 3, a Phase III trial of Tomtovok (afatinib) compared to chemotherapy (pemetrexed/cisplatin) in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC). Three lung cancer symptoms – cough, dyspnea (shortness of breath), and pain – were analyzed and results showed that a higher proportion ...

EU approval for Dacogen (Janssen Cilag) for treatment of Acute Myeloid Leukemia

Astex Pharmaceuticals has announced that Janssen-Cilag International NV was notified that the European Commission has approved the marketing authorization for Dacogen (decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary Acute Myeloid Leukemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction ...

Belinostat (TopoTarget/Spectrum) success in BELIEF study for PTCL

The pivotal BELIEF trial (PXD101-CLN-19) evaluating the efficacy and safety of belinostat from Topo Target A/S for the treatment of patients with relapsed/refractory Peripheral T-Cell Lymphoma (PTCL) met its primary endpoint. A Special Protocol Assessment agreement with the FDA requires the BELIEF trial to reach an objective response rate (ORR) of at least 20% and this objective was met. Data ...

FDA approves Stivarga (Bayer/Onyx Pharma) for metastatic Colorectal Cancer

The FDA has on 27th September 2012 approved Stivarga (regorafenib) from Bayer HealthCare and Onyx Pharma for the treatment of patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy). The approval of Stivarga is based on results ...

CHMP recommends Avastin with chemotherapy and gemcitabine for Ovarian Cancer

Roche announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Avastin (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) as a treatment for women with recurrent, platinum-sensitive ovarian cancer. Ovarian cancer has the highest mortality rate of all gynaecological cancers. Almost 230,000 women worldwide are diagnosed with this cancer ...

CHMP recommends Picato (Leo Pharma) for treatment of Actinic Keratosis

On 20 September 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Picato, 150 micrograms/g, 500 micrograms/g gel intended for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic Actinic Keratosis in adults. The applicant for this medicinal product is LEO Pharma A/S....

CHMP recommends Votubia (Novartis) for Renal Angiomyolipoma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Votubia (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or ...

FDA approves somo-v Automated Breast Ultra Sound System for dense breast imaging

The FDA on 18 September 2012 approved the somo-v Automated Breast Ultrasound System (ABUS) from U-Systems Inc., which is the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.

Dense breasts have a high amount of connective and glandular tissue ...

Boehringer files Tomtovok at EMA for NSCLC

Boehringer Ingelheim has announced the submission of a Marketing Authorisation Application to the European Medicines Agency for approval of Tomtovok (afatinib) the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive Non-Small Cell Lung Cancer. Afatinib has demonstrated unprecedented efficacy versus chemotherapy in the Phase III LUX-Lung 3 registration trial, which provides pivotal support ...

Baxter acquires EU licence to rigosertib from Oncanova

Baxter International Inc. and Onconova Therapeutics Inc.have announced that they have entered into a European licensing agreement for rigosertib, a novel targeted anti-cancer compound from Onconova currently in a Phase III study for the treatment of a group of rare hematologic malignancies called Myelodysplastic Syndromes and in a Phase II/III study for Pancreatic Cancer. Under the terms of the agreement, ...

Merck Serono withdraws EMA application for treatment of Non Small Cell Lung Cancer

Merck-Serono announced the strategic decision to voluntarily withdraw the marketing authorization application to the European Medicines Agency of a label extension for Erbitux (cetuximab) in combination with standard first-line platinum-based chemotherapy in patients with advanced or metastatic Non-Small Cell Lung Cancer with high epidermal growth factor receptor expression. The decision to withdraw the application was based on feedback from European ...

Positive results of Phase III study of Zytiga (Janssen Biotech) in metastatic Prostate Cancer

Results of a Phase III trial of Zytiga (abiraterone acetate), from Janssen Biotech, confirm it offers a significant survival benefit to patients with castration-resistant metastatic Prostate Cancer. The study, the first Phase III trial to show a significant survival benefit for this kind of drug, involved 1195 patients in thirteen countries, and compared the effects of prescribing Zytiga and the ...

Phase II success for resminostat (4SC) in Liver Cancer

4SC AG announced the publication of convincing overall survival data from a Phase II study with its lead anti-cancer drug resminostat applied as a novel combination therapy approach with sorafenib in second-line advanced Liver Cancer at the 2012 annual meeting of the International Liver Cancer Association in Berlin, Germany, on 16 September 2012.

The international, open-label, two-arm SHELTER ...

Phase II success for bavituximab (Peregrine Pharma) in NSCLC

Interim results were presented from a 121 patient randomized, double-blind, placebo-controlled Phase IIb trial of bavituximab from Peregrine Pharma, in patients with refractory Non-Small Cell Lung Cancer (NSCLC). The blinded study evaluated two dose levels of bavituximab (bavituximab-containing arms) given with docetaxel versus docetaxel plus placebo (control arm). The interim data showed a statistically significant improvement in overall survival (Hazard ...

F-18 PET helps predict disease-free survival for Breast Cancer patients

A new study shows that disease-free survival for invasive ductal Breast Cancer (IDC) patients may be easier to predict with the help of F-18-fludeoxyglucose positron emission tomography (PET)/computed tomography (CT) scans. Data show that high maximum standard uptake value (SUVmax) of F-18-FDG in the lymph nodes prior to treatment could be an independent indicator of disease recurrence. Researchers followed 65 ...

EC approves Inlyta (Pfizer) for Real Cell Carcinoma

The European Commission (EC) has granted marketing authorization for Inlyta (axitinib) from Pfizer for the treatment of adult patients with advanced Renal Cell Carcinoma a type of kidney cancer, after failure of prior treatment with sunitinib or a cytokine. The Inlyta data demonstrates a statistically significant improvement in progression free survival compared with sorafenib, and supports the continued role for ...

FDA approves Bosulif (Pfier) for treatment of PH+CML

Pfizer Inc. has announced that the FDA has approved Bosulif (bosutinib),an Abl and Src kinase inhibitor, for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) with resistance, or intolerance to prior therapy. Patients in the registrational trial included patients who were previously treated with imatinib [Gleevec] or imatinib plus at ...

FDA approves Afinitor Disperz(Novartis) for SEGA Tumours

The FDA has on 29 August 2012 approved Afinitor Disperz (everolimus tablets for oral suspension; Novartis), a new pediatric dosage form of Afinitor (everolimus) indicated for treatment of Tuberous Sclerosis Complex (TSC) in patients aged >1 year who are diagnosed with Subependymal Giant Cell Astrocytoma (SEGA) that cannot be treated with surgery. Afinitor Disperz is the first approved pediatric-specific dosage ...

Bayer HealthCare submit NDA for BAY 73-4506 as treatment for GIST

Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA for BAY 73-4506 (regorafenib) for the treatment of metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST) in patients whose disease has progressed despite prior treatment.

The submission is based on data from the pivotal Phase III GRID trial, which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free ...

Ariad Pharma files ponatinib at EMA for CML and Ph+ALL

Ariad Pharmaceuticals has submitted its marketing authorisation application to the European Medicines Agency for ponatinib for resistant or intolerant Chronic Myeloid Leukaemia and Philadelphia-chromosome positive Acute Lymphoblastic Leukaemia.The drug was filed in the US for these indications in July 2012....

FDA approves Xtandi(Astellas/Medivation)to treat castration- resistant Prostate Cancer

The FDA has on 31 August 2012 approved Xtandi (enzalutamide) from Astellas/Medivation to treat men with late-stage (metastatic) castration-resistant Prostate Cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA’s priority review program. The program provides for ...

Positive Phase III EMILIA study data for T-DM1 (Genentech/Roche) in Breast Cancer patients confirmed

Genentech has announced updated results from the Phase III EMILIA study, which showed that trastuzumab emtansine (T-DM1) significantly extended the lives (improved overall survival) of people with HER2-positive metastatic Breast Cancer (mBC) compared to the combination of lapatinib and Xeloda (capecitabine). The EMILIA study, in people with HER2-positive mBC who had previously received Herceptin (trastuzumab) and taxane chemotherapy, has now ...

EU approves Zyclara (Meda AB) for Actinic Keratoses

Meda AB has announced that the European Commission (EC) has granted marketing authorization for Zyclara (imiquimod 3.75% cream) in the European Union. Zyclara is a patented product for the treatment of Actinic Keratosis. The approval is valid in all EU countries....

Campath/MabCampath (Sanofi/Genzyme) withdraws marketing in EU and US for oncology indications.

Sanofi/Genzyme have withdrawn MabCampath (alemtuzumab) from the European market and established a free distribution programme for B-cell CLL users. In the United States the FDA licence will be maintained but a free Campath Distribution Program will offer the drug freely to patients. The intention is to avoid confusion between Campath/MabCampath and the newly developed version of alemtuzumab for which Sanofi/Genzyme ...

Positive results in Phase III study of MDV 3100 (Medivation Inc) in Prostate Cancer patients

Results of a Phase III clinical trial of the drug MDV 3100 (enzalutamide), from Medivation Inc, show the drug extends life by an average five months in the most advanced stages of Prostate Cancer.

The study, AFFIRM, followed 1199 patients whose cancer that had progressed despite both hormonal and chemotherapy treatments, with 2/3 of patients receiving the drug MDV 3100 ...

Benefit assessment finds no clear advantage of Halaven (Eisai) for Breast Cancer patients

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Halaven (eribulin mesylate), from Eisai, offers an added benefit compared with the present standard therapy in Breast Cancer patients. According to the results of the assessment, the currently available evidence provides "hints" that Halaven may increase survival time in patients for whom ...

NICE recommends Xgeva for as a treatment for people with bone metastases from most solid cancer tumours including Breast Cancer

The National Institute for Health and Clinical Excellence (NICE) has published final draft guidance recommending Xgeva(denosumab) from Amgen/GSK as a treatment for people with bone metastases from most solid cancer tumours.It provisionally recommends denosumab for the prevention of skeletal-related events in: •people with bone metastases from breast cancer and •people with bone metastases from solid tumours (other than breast or ...

Positive data from Phase III study of Xgeva (Amgen) in Breast Cancer patients

Treatment with Xgeva (denosumab), from Amgen, resulted in a greater reduction in skeletal-related events in patients with Breast Cancer that spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a Phase III study published in Clinical Cancer Research. The study randomly assigned 2,046 patients to receive subcutaneous denosumab and ...

Phase II trials show improved survival with Caprelsa (AstraZeneca) for medullary Thyroid Cancer

A new study shows that the chemotherapy drug vandetanib Caprelsa (vandetanib) from AstraZeneca, may extend life for some Thyroid Cancer patients. The results of Phase II trials showed that patients taking the drug lived for 11 months without the cancer progressing, compared with six months for those receiving a placebo. The report was published online Aug. 13 in the journal ...

Torisel (Pfizer) fails in combination trial with Avastin in Renal Cell Carcinoma

Pfizer Inc. announced that the Phase III INTORACT trial (B1771006), evaluating the combination of bevacizumab plus Torisel (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-?-2a) in the first-line treatment of patients with advanced Renal Cell Carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population. Additional efficacy endpoints ...

Positive results from Phase III study of Avastin (Genentech/Roche) in Brain Cancer patients

The Phase III AVAglio study of Avastin (bevacizumab), from Genentech/Roche, plus radiation and temozolomide chemotherapy in people with newly diagnosed Glioblastoma met its co-primary endpoint of a significant improvement in progression-free survival (PFS). In the study, Avastin in combination with radiation and temozolomide chemotherapy significantly extended the time people with this aggressive form of primary Brain Cancer lived without their ...

FDA approves Marqibo (Talon Therapeutics) for Ph-ALL

The FDA has approved the orphan drug Marqibo (vincristine sulfate liposomes injection)from Talon Therapeutics, as a treatment for patients with Philadelphia chromosome negative (Ph-) Acute Lymphoblastic Leukemia (ALL). Marqibo is approved for patients whose leukemia has returned (relapsed) two or more times, or whose leukemia has progressed following two or more regimens of anti-leukemia therapy.

Marqibo contains vincristine, a ...

NKTR 102 (Nektar) update on cancer trials

Nektar Therapeutics announced the start of a Phase II study of NKTR 102 (etirinotecan pegol) in patients with bevacizumab (Avastin)-resistant high-grade Glioma being conducted at Stanford Cancer Institute. The primary endpoint of the Phase II study is the six-week progression free survival (PFS) rate. Secondary endpoints include survival from time of first etirinotecan pegol infusion, overall survival from date ...

Ganitumab (Amgen) Phase III trial stopped in Pancreatic Cancer

Amgen has announced a decision to stop the ganitumab (AMG 479) Phase III GAMMA (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas) trial following the recommendation of an independent Data Monitoring Committee (DMC) overseeing the trial. Based on the review of a pre-planned interim analysis, the DMC concluded that the addition of ganitumab to gemcitabine is unlikely to ...

EMA approves Votrient (Glaxo Smith Kline) for patients with Soft Tissue Sarcoma

The European Commission has granted marketing authorisation for the use of Votrient (pazopanib), from Glaxo Smith Kline, for treatment of patients with advanced Soft Tissue Sarcoma (aSTS) who have received prior chemotherapy or have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes. According to results of the ...

Talactoferrin fails FORTIS-M trial for NSCLC

The FORTIS-M trial of talactoferrin from Aggenix AG, investigated the effect of talactoferrin plus best supportive care (BSC) compared with placebo and BSC in patients with Stage IIIb/IV Non Small Cell Lung Cancer, whose disease had progressed following two or more prior treatment regimens. Results showed that median overall survival in the talactoferrin arm was just 7.5 months compared to ...

Glaxo Smith Kline files NDA and MAA for dabrafenib in Metastatic Melanoma patients

Glaxo Smith Kline has filed a New Drug Application to the FDA for dabrafenib for the treatment of patients with unresectable or Metastatic Melanoma with BRAF V600 mutation as detected by an FDA-approved test. The company has also filed a Marketing Authorisation Application to the EMA for dabrafenib for treating adult patients with the same mutation. This follows positive results ...

GSK files trametinib at the FDA for Metastatic Melanoma

GSK has filed trametinib, a drug developed by Japan Tobacco , at the FDA to treat unresectable Metastatic Melanoma and is planning a EU filing. The molecule targets patients with BRAF V600 mutation positive forms of Metastatic Melanoma. The V600 mutation applies to some 60% of Melanoma patients. A companion diagnostic has already been filed by BioMerieux. The application is ...

Updated results of TIVO-1 study of tivozanib in Renal Cell Carcinoma

Aveo Pharma and Astellas reported detailed data from TIVO-1 (Tivozanib Versus Sorafenib in 1st line RCC), a global, randomized, Phase III, superiority clinical trial evaluating the efficacy and safety of tivozanib compared to sorafenib in 517 patients with advanced Renal Cell Carcinoma (RCC). The data showed that tivozanib successfully demonstrated superiority over sorafenib in the primary endpoint of progression-free ...

FDA approves Zaltrap ( Regeneron/Sanofi) for treatment of metastatic Colorectal Cancer

The FDA has approved Zaltrap (ziv-aflibercept) from Regeneron/ Sanofi for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with Colorectal Cancer. Zaltrap is an angiogenesis inhibitor that inhibits the blood supply to tumors. It is intended for patients whose cancer has spread to other parts of the body (metastatic) and whose tumors ...

Combination Faslosdex and Arimidex success in Breast Cancer trial

A report in 2 August issue of NEJM recorded that a combination of Arimidex ( anastrozole) and oestrogen receptor modulator Faslodex (fluvestrant) is more effective than either Arimidex or Faslodex alone or sequentially administered in treating post menopausal hormone recepttor (HR) positive metastatic breast cancer. Combination therapy gave a signiicant improvement in secondary endpoint of overall survival by more than ...

FDA will review cabozantinib (Exelixis Inc) as a treatment for Thyroid Ccancer on 29 November 2012

Exelixis, Inc.announced that the FDA has accepted for filing the New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary Thyroid Cancer (MTC). The FDA also granted priority review designation to the NDA for cabozantinib. The Prescription Drug User Fee Act (PDUFA) action date is November 29, 2012....

EU approves Afinitor (Novartis)for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced Breast Cancer

The European Commission has approved Afinitor (everolimus) tablets from Novartis for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced Breast Cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

The approval was based on the Phase III BOLERO-2 (Breast cancer trials of ...

Phase II proof of concept trial for APG 101 (Apogenix) is confirmed for Glioblastoma Multiforme

Apogenix announced the figures that confirm that the primary objective of its Phase II proof-of-concept trial investigating its lead product, APG101, as a second line treatment of Glioblastoma Multiforme (GBM), had been met, The company expects to unveil overall survival data from the study in the fourth quarter of 2012.In March 2012 the company reported that the primary objective of ...

Two Phase III studies of OMS ElectroChemotherapy (OncoSec Medical) show QoL benefits

Data from an interim analysis of two Phase III trials, HNBE-01 and HNBE-02, using OMS ElectroChemotherapy, from OncoSec Medical, to treat locally recurrent and second primary squamous cell carcinoma of the head and neck enhances patients quality of life.

In these studies, electrochemotherapy was compared against surgery for quality of life, safety, survival and local control at eight months, ...

No benefit of Tarceva (Genentech/Roche) for patients with Liver Cancer

A Phase III trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib), from Genentech/Roche, to sorafenib did not improve overall survival for patients with unresectable Liver Cancer vs. sorafenib alone. The international SEARCH trial randomised 720 patients with advanced Liver Cancer and examined whether the addition of Tarceva to sorafenib prolongs survival as compared to sorafenib alone ...

CHMP recommends Adcetris ( Takeda) for CD 30+ Hodgkin Lymphoma

On 19 July 2012, the CHMP adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Adcetris (brentuximab vedotin) from Takeda/Millennium/Seattle Genetics, 50 mg, powder for concentrate for solution for infusion, intended for the treatment of of adult patients with relapsed or refractory CD30+ Hodgkin Lymphoma (HL): (1) following autologous stem cell transplant (ASCT) ...

CHMP recommends Dacogen (Janssen/Eisai) for Acute Myeloid Leukemia

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dacogen, 50 mg, powder for concentrate for solution for infusion, from Eisai/Janssen and intended for the treatment of Acute Myeloid Leukaemia. Dacogen was designated as an orphan medicinal product on 8 June ...

CHMP recommends Xalkori (Pfizer) for treatment of NSCLC

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Xalkori (crizotinib), 200 mg, 250 mg, hard capsule from Pfizer and intended for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) . ...

CHMP refuses recommendation of Istodax( Celgene) for T-cell Lymphoma

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Xalkori (crizotinib), 200 mg, 250 mg, hard capsule from Pfizer and intended for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) . ...

Brivanib (BMS) fails Phase III trial for Hepatocellular Carcinoma

Bristol Myers Squibb (BMS) announced the results of the phase III BRISK-FL clinical trial of the investigational agent brivanib versus sorafenib as first-line treatment in patients with advanced Hepatocellular Carcinoma (liver cancer). The study did not meet its primary overall survival objective based upon a non-inferiority statistical design. BMS is considering options for the ongoing brivanib development program. Ongoing clinical ...

FDA approves Kyprolis (Onyx Pharma) for Multiple Myeloma

The FDA has approved Kyprolis (carfilzomib) from Onyx Pharma to treat patients with Multiple Myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy. A form of blood cancer that arises from plasma cells, Multiple Myeloma usually grows in bone marrow, the soft, spongy tissue found inside most bones. The bone marrow ...

FDA approves Afinitor for HER-2 negative Breast Cancer

The FDA has approved Afinitor (everolimus)tablets from Novartis for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative Breast Cancer (advanced HR+ breast cancer) in combination with exemestane after failure of treatment with letrozole or anastrozole. The approval was based on a randomized, double-blind, placebo-controlled, multi-center trial called BOLERO-2 (Breast cancer trials of OraL EveROlimus-2), which evaluated 724 postmenopausal ...

Review shows some benefit from Avastin (Genentech/Roche) for Breast Cancer patients

A new review finds that Avastin (bevacizumab), from Genentech/Roche, offers modest benefit in slowing disease progression in advanced-stage Breast Cancer patients. The study examined Avastin's efficacy when combined with conventional chemotherapy treatment, but no overall improvement in survival was noted using this combination.

The review examined seven trials involving 4,032 patients with Breast Cancer and found that adding ...

FDA approves Erbitux(Eli Lilly/BMS)for first line combination treatment of Kras wild type EGFR expressing metastatic Colorectal Cancer

Erbitux (cetuximab), marketed by BMS/Eli Lilly in the U.S.,in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) has been granted full approval by the FDA for the first-line treatment of patients with KRAS mutation-negative (commonly known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic Colorectal Cancer (mCRC) as determined by FDA-approved tests for this use. ERBITUX is not ...

FDA approves Therascreen KRAS RGQ PCR Kit (Qiagen) for use with Colorectal Cancer patients

The FDA has given marketing approval for the Therascreen KRAS RGQ PCR Kit, from Qiagen, to provide guidance on the use of Erbitux (cetuximab) as a treatment in patients with metastatic Colorectal Cancer. The Therascreen KRAS RGQ PCR Kit is a molecular diagnostic kit for detection of 7 somatic mutations in the KRAS gene using real-time PCR on the Rotor-Gene ...

Janssen Cilag withdraws application at EMA for Velcade in Follicular Lymphoma

Janssen Cilag has withdrawn its application for EU approval for the use of Velcade (bortezomib) in combination with rituximab as a treatment for patients with relapsed Follicular non-Hodgkin Lymphoma. The European Medicines Agency said it had been formally notified by the company that it was withdrawing the application because the Committee for Medicinal Products for Human Use indicated that the ...

Erbitux (Merck Serono) fails EXPAND trial for Gastric Cancer

Merck Serono has announced the outcome of the Phase III clinical trial EXPAND, which assessed Erbitux (cetuximab) in combination with cisplatin and capecitabine as a 1st-line treatment for patients with advanced Gastric Adenocarcinoma including adenocarcinoma of the gastro-esophageal junction. The trial did not meet its primary endpoint of extending the length of time that patients live without their disease getting ...

Ixazomib (Takeda/Millennium) enters Phase III trials for Multiple Myeloma

Takeda and Millennium Oncology have begun a Phase III development programme for ixazomib citrate (MLN 9708), the first oral proteasome inhibitor to enter clinical trials for Multiple Myeloma and to be a possible successor to the Velcade. The trial is TOURMALINE-MM1 which will assess MLN 9708 in patients with relapsed and/or refractory Multiple Myeloma at sites in North and South ...

NICE recommends Zytiga (Janssen Cilag) for metastatic Prostate Cancer

The National Institute for Health and Clinical Excellence (NICE) has published final guidance endorsing Zytiga (abiraterone acetate) from Janssen Cilag as an NHS treatment option for patients in England and Wales with metastatic castration resistant Prostate Cancer (mCRPC), if their disease has progressed despite having received a docetaxel-containing chemotherapy regimen....

FDA give premarket approval for the Prostate Health Index (Beckman Coulter) to test for Prostate Cancer

The FDA has given Premarket Approval (PMA) for the Prostate Health Index (PHI), from Beckman Coulter. The PHI test is a non-invasive blood test that is 2.5-times more specific in detecting Prostate Cancer than PSA (prostate-specific antigen) in patients with PSA values in the 4-10 ng/mL range. Typically, physicians recommend that men with a PSA in that range consider a ...

MDV 3100 (Astellas) for Prostate Cancer submitted to EMA for marketing authorisation

Astellas has submitted a European marketing authorisation application to the EMA for MDV 3100 (enzalutamide) for the treatment of men with metastatic castration-resistant Prostate Cancer who have been previously treated with docetaxel-based chemotherapy. The submission follows positive results from the pivotal Phase III AFFIRM study, which confirmed that enzalutamide demonstrated a statistically significant improvement (p<0.0001) in overall survival with a ...

CHMP recommends subcutaneous Velcade (Janssen) for Multiple Myeloma

The CHMP has granted a positive opinion recommending approval of subcutaneous administration of Velcade (bortezomib), from J&J Janssen Cilag, for patients with Multiple Myeloma. Subcutaneous bortezomib has fewer side effects and offers greater convenience for patients, with similar efficacy compared to intravenous bortezomib...

CHMP recommends EU approval of Zyclara (Meda) for Actinic Keratoses

The CHMP has adopted a positive opinion regarding marketing authorization of Zyclara (imiquimod), from Meda, for the treatment of Actinic Keratoses (AK) on large skin areas. Zyclara shares the same active ingredient as Aldara and while both are approved by the FDA for the treatment of AK, there are key differences: Zyclara is indicated for daily use on an accelerated ...

Study shows positive results with dabrafenib (Glaxo Smith Kline) in Melanoma patients

A new study compared dabrafenib, from Glaxo Smith Kline, with the most commonly used existing treatment, dacarbazine (DTIC), in 250 patients suffering from spreading or inoperable BRAF-positive Melanoma. Half of the patients demonstrated a partial (47%) or complete response (3%) to the treatment in an independent review. By comparison, just 6% of patients treated with DTIC showed an improvement. Progression-free ...

FDA Advisory Committee recommends Kyprolis(Onyx) for Multiple Myeloma

Onyx Pharmaceuticals announced that the FDA Oncologic Drugs Advisory Committee determined by a vote of 11-0 (with 1 abstention) that, in patients with relapsed and refractory Multiple Myeloma who have received at least two prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent, the benefit-risk assessment is favorable for the use of Kyprolis (proposed brand name ...

CHMP recommends Afinitor (Novartis) for (HR+) HER2/neu-negative advanced Breast Cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Afinitor (everolimus) tablets, from Novartis, in combination with exemestane, for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced Breast Cancer, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.The CHMP opinion ...

CHMP requires more data for Revlimid (Celgene) application for maintenance therapy in Multiple Myeloma

Celgene has decided to withdraw the new indication submission to the Committee for Medicinal Products for Human Use (CHMP) for Revlimid (lenalidomide), which was intended for the maintenance treatment of newly diagnosed Multiple Myeloma patients who have not progressed following initial treatment with melphalan, prednisone and Revlimid (lenalidomide), or maintenance therapy following autologous stem cell transplantation. In response to the ...

Xalkori(Pfizer)success in Phase III trial in ALK-positive advanced NSCLC

The PROFILE 1007 study met its primary endpoint, demonstrating that Xalkori (crizotinib) from Pfizer significantly improved progression-free survival when compared with pemetrexed or docetaxel, in previously treated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). PROFILE 1007 is the first randomized Phase III study in ALK-positive advanced NSCLC patients. Xalkori received an accelerated approval by the ...

Three-year follow-up data on Sprycel (Otsuka/BMS) shows fast, deep response in CML patients

Results from the 3-year follow-up of the DASISION trial shows that first-line treatment with Sprycel (dasatinib), from BMS and Otsuka, results in faster and deeper response rates compared with Gleevec in patients with newly diagnosed Philadelphia+ Chronic Myeloid Leukaemia. An exploratory analysis of the study suggests that patients with a deeper molecular response at three months (defined as having a ...

Two papers and an editorial in the New England Journal of Medicine hail Erivedge (Roche) as great advance in BCC

An editorial accompanying 2 papers in the New England Journal of Medicine hails Erivedge (vismodegib), from Roche, as "the greatest advance in therapy yet seen" for patients with advanced Basal Cell Carcinoma. Following its first tests in 2007, the FDA approved the drug earlier this year. FDA approval in five years is a remarkable achievement because clinical trials typically progress ...

NICE does not recommend Zelboraf(Roche) for Metastatic Melanoma

NICE, the health technology appraisal institute for England and Wales, has not recommended Zelboraf (vemurafenib) from Roche, for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma in its daft guidance. NICE was uncertain about both the long-term effect of drug on survival and its cost, even though Roche had put forward a patient access scheme....

Six-year follow up on Phase III study of Sprycel (BMS / Otsuka) shows positive results for CML patients

Results from a Phase III study of Sprycel (dasatinib), from BMS and Otsuka, in Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukaemia (CP-CML) adult patients shows progression-free survival of 49.3% and an overall survival of 71% with 6% of patients progressing to accelerated or blast phase on study at six years of follow-up. Study CA180-034 was designed to assess the efficacy ...

J&J Janssen Cilag submits supplemental applications to extend use of Zytiga in Prostate Cancer

J&J Janssen Cilag International has submitted a type II variation to the EMA for Zytiga (abiraterone acetate). Simultaneously, Janssen Research & Development submitted a supplemental New Drug Application to the FDA. Both applications are intended to extend the use of Zytiga administered with prednisone for patients with metastatic castration resistant Prostate Cancer (mCRPC) who are asymptomatic or mildly symptomatic after ...

NICE recomends Xgeva (Amgen) for bone metastases

The latest draft guidance from NICE recommends Xgeva (denosumab)from Amgen: •For adults with bone metastases from breast cancer •For adults with bone metastases from solid tumours other than breast and prostate only if zoledronic acid or disodium pamidronate would otherwise be prescribed for these patients....

FDA approves Perjeta (Genentech/Roche) for combination use in metastatic Breast Cancer

Genentech/Roche announced that the FDA has approved Perjeta (pertuzumab). Perjeta is approved in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic Breast Cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. This approval is based on data from a Phase III study which showed that people with previously ...

Positive results for Phase III study of enzalutamide (Medivation) for Prostate Cancer treatment

Results from a Phase III clinical trial show that enzalutamide (formerly MDV 3100), from Medivation, prolongs lives of patients with Prostate Cancer. Patients in the AFFIRM trial who had stopped responding to chemotherapy evaluated 27 factors, including pain and energy levels and ability to work while taking MDV 3100. Results showed that around 43% of men taking the drug experienced ...

Exelixis reports results for XL 184 in Thyroid Cancer

Top line results were reported by Exelixis for XL 184 (cabozantinib) for the primary endpoint in the 330-patient Phase III EXAM study in patients with locally advanced or metastatic medullary Thyroid Cancer which showed a 7.2-month improvement in progression-free survival (PFS) with cabozantinib compared to placebo - 11.2 months of PFS versus four months. n terms of secondary endpoints, the ...

Orexo AB regains US marketing rights to Abstral

Orexo AB have regained from 1 January 2013 US rights to market Abstral (fentanyl citrate sublingual) from Kyowa Hakko Kirin/ProStraken. The emphasis in marketing in the US will now be on pain specialists and not oncologists. ProStraken is a company focused on oncology. Abstral will be followed in the US by OX 219, a treatment for opioid dependence. OX 219 ...

FDA reject Taltorvic (Merck Inc) for Sarcomas

The FDA has issued a complete response letter to an application for Sarcoma drug Taltorvic (ridaforolimus), from Merck Inc., saying it cannot approve the application in its present form, and "that additional clinical trial(s) would need to be conducted to further assess safety and efficacy". The rejection follows a vote in March in which the agency's Oncologic Drugs Advisory Committee ...

Treanda (Teva/Mundipharma) success in NHL study

Treanda/Levact(bendamustine) from Teva/Mundipharma/Napp combined with Rituxan/MabThera outperformed the current standard of care in treating Non-Hodgkin's Lymphoma (NHL).In the trial, which included more than 500 patients, Treanda slowed NHL growth for 55 months, compared with just 35 months in those patients taking the standard four-drug treatment. After 32 months, 40 percent of Treanda patients experienced full remission, while 31 percent went ...

Trametinib and dabrafenib(GSK) success in BREAK 3 and METRIC studies for Melanoma

GSK announced at the Annual Meeting of the American Society of Clinical Oncology in Chicago positive results for investigational BRAF and MEK inhibitors dabrafenib and trametinib.The BREAK 3 study of dabrafenib (BRAF inhibitor) and the METRIC study of trametinib (MEK inhibitor) demonstrated a statistically significant benefit in the length of time patients with BRAF V600 mutation positive advanced or Metastatic ...

Tivantinib (Daiichi Sankyo.) in Phase II study of Hepatocellular Carcinoma

ArQule, Inc and Daiichi Sankyo Co., have announced at ASCO 2012 (abstract number 4006)- final results from a randomized, placebo-controlled, double-blind, phase II clinical trial with the selective MET inhibitor tivantinib as a single-agent, investigational, second-line treatment in Hepatocellular Carcinoma (HCC). The 107 patients in the trial had unresectable HCC and had disease progression after first-line therapy or were unable ...

Treanda(Teva/Mundipharma)success in NHL study

Treanda/Levact(bendamustine) from Teva/Mundipharma/Napp combined with Rituxan/MabThera outperformed the current standard of care in treating Non-Hodgkin's Lymphoma (NHL).In the trial, which included more than 500 patients, Treanda slowed NHL growth for 55 months, compared with just 35 months in those patients taking the standard four-drug treatment. After 32 months, 40 percent of Treanda patients experienced full remission, while 31 percent went ...

Phase III GRID study of BAY 73-4506 (Bayer HealthCare) for GIST meets primary endpoint

The Phase III GRID trial evaluating BAY 73-4506 (regorafenib), from Bayer HealthCare, in patients with metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST) met its primary endpoint. The median PFS was 4.8 months in the BAY 73-4506 arm versus 0.9 months in the placebo arm. The most common adverse events included hand-foot skin reaction (56.1% vs.15.2%), hypertension (48.5% vs. 16.7%) and ...

Positive results from LUX-Lung 3 trial of Tomtovok (Boehringer) in NSCLC patients

LUX-Lung 3, the pivotal Phase III clinical trial investigating Tomtovok (afatinib), from Boehringer, in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor mutation (EGFR M+), met its primary endpoint of progression-free survival (PFS). LUX-Lung 3, which compares Tomtovok to pemetrexed/cisplatin, is the largest Phase III trial to date in first-line EGFR ...

Positive Phase III data for T-DM1 (Genentech/Roche) Breast Cancer patients

The Phase III EMILIA study of T-DM1 (trastuzumab emtansine), from Genentech / Roche, met its co-primary endpoint of a significant improvement in the time people with HER2-positive metastatic Breast Cancer lived without their disease getting worse. The study showed that the risk of disease worsening or death was reduced by 35 percent for people who received T-DM1 compared to those ...

Positive data from Phase III trial of Avastin (Genentech/Roche) for Colorectal Cancer patients

Results from ML18147, a Phase III study in metastatic Colorectal Cancer that evaluated Avastin (bevacizumab), from Genentech/Roche, continued with second-line chemotherapy in people who received initial Avastin plus first-line chemotherapy, show the study met its primary endpoint of a significant increase in overall survival. In the study, the relative risk of death was reduced by 19 percent for people who ...

Positive data from Phase III study of Abraxane (Celgene Oncology) for NSCLC patients

A retrospective analyses of CA-031, the Phase III study where Non-Small Cell Lung Cancer patients received either Abraxane (nab-paclitaxel), from Celgene Oncology, plus carboplatin or paclitaxel plus carboplatin demonstrated a higher overall response rate for patients in the Abraxane arm compared to those in the paclitaxel arm (33% vs. 25%). A second analysis evaluating patients with squamous-cell histology and non-squamous ...

Positive data from Phase III AURELIA trial of Avastin (Genentech/Roche) for Ovarian Cancer patients

A phase III study evaluating Avastin (bevacizumab), from Genentech/Roche, in combination with standard chemotherapy in women with Ovarian Cancer shows positive results. Data from the AURELIA study shows the risk of progression was reduced by 52 percent in women whose disease had worsened due to resistance to platinum-containing chemotherapy and who received Avastin plus chemotherapy compared with those who received ...

Positive Phase III data for Zytiga (J&J Janssen Cilag) plus prednisone for Prostate Cancer

Analysis of the Phase III study, COU-AA-302, demonstrated that patients with metastatic castration-resistant Prostate Cancer (mCRPC) treated with Zytiga (abiraterone acetate), from J&J Janssen Cilag, plus prednisone, showed a statistically significant improvement in radiographic progression-free survival (rPFS) and all secondary endpoints compared to patients treated with placebo plus prednisone. The median rPFS in the control arm was 8.3 months but ...

EMA finds MabThera (Genentech/Roche) safe to use.

The EMA has cleared MabThera (rituximab), from Genentech/Roche, as safe after an assessment found that contamination at the manufacturer's bioreactors poses little threat. This follows a contamination scare at Roche's facility in Vacaville, California, US. MabThera is approved to treat Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukaemia, as well as Rheumatoid Arthritis....

Carbozantinib (Exelixis) enters Phase III for metastatic castration resistant Prostate Cancer

COMET-1 trial is initiated for cabozantinib from Exelixis Inc., and is a double-blind, placebo-controlled Phase III study that will include up to 240 international sites. The trial is designed to enroll 960 patients with metastatic castration-resistant Prostate Cancer (mCRPC) who have previously been treated with docetaxel, and abiraterone acetate and/or MDV3100. All patients will have bone metastases and there is ...

Phase III trial of TAS 102 (Taiho) for Colorectal Cancer begins in June

A global Phase III clinical trial for the novel combination antimetabolite TAS 102, from Taiho, to treat metastatic Colorectal Cancer will begin in June. The trial, named RECOURSE, is a randomized, double-blind, placebo-controlled Phase III trial that compares TAS 102 with best supportive care to investigate the efficacy and safety of TAS 102 when administered to patients with advanced recurrent ...

Positive data from PIX301 trial of Pixuvri (Cell Therapeutics) for Non Hodgkin Lymphoma

New results have been released from the Phase III trial of Pixuvri (pixantrone dimaleate), from Cell Therapeutics, for patients with relapsed or refractory, aggressive Non Hodgkin Lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The PIX301 trial enrolled 140 patients who were randomized to receive either Pixuvri or another single-agent drug. Pixuvri ...

BOLERO-2 study update for Afinitor (Novartis) in HR+ Breast Cancer presented at ASCO

An 18-month analysis from the Phase III BOLERO-2 study from Novartis confirms that Afinitor (everolimus) plus exemestane, an aromatase inhibitor, more than doubled the time postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer lived without tumor growth (progression-free survival; PFS).The updated results show median PFS for everolimus plus exemestane was 7.8 months compared to 3.2 months with hormonal therapy ...

Tasgina updates of ENEST programme in Ph+CML presented at ASCO meeting

Two Phase III studies from the ENEST clinical research program, demonstrate that twice as many adult patients with Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) in chronic phase treated with Tasigna (nilotinib) from Novartis achieved deeper levels of response compared to those treated with imatinib. These findings were first presented at the 2011 American Society of Hematology Annual Meeting and ...

CHMP recommends EU approval of Inlyta (Pfizer) for Renal Cell Carcinoma

The EMA's CHMP has recommended the marketing authorisation of Inlyta (axitinib), from Pfizer, for the treatment of adult patients with advanced Renal Cell Carcinoma, after failure of prior treatment with sunitinib or a cytokine. This drug therapy is designed to selectively inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which can influence tumour growth, ...

Early success for CDX 011 (Celldex) in Phase II Breast Cancer study

Preliminary results were announced from the randomized Phase IIb EMERGE study of CDX-011 (glembatumumab vedotin) antibody drug conjugate from Celldex Therapeutics, in patients with glycoprotein NMB (GPNMB) expressing, advanced, heavily pretreated Breast Cancer. Preliminary results suggest that CDX-011 induces impressive response rates compared to current, available therapies in patients with advanced, refractory breast cancers with high GPNMB expression.In this high ...

Enzalutamide is filed at FDA by Medivation for Prostate Cancer

Medivation has submitted a New Drug Application (NDA) to the FDA for enzalutamide (formerly MDV3100). The compound has been studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen ...

Dabrafenib (GSK) impressive in Metastatic Melanoma

A total of 184 patients with incurable solid tumours were enrolled (156 with Metastatic Melanoma) in a Phase 1 trial and given escalating doses of dabrafenib from Glaxo Smith Kline. The investigators established a recommended phase II dose (RP2D) of 150 mg twice daily.In the second stage, efficacy at the RP2D was studied in three groups of patients with BRAF-mutant ...

New drug application filed with FDA for BAY 73-4506 (Bayer HealthCare) for metastatic Colorectal Cancer

Bayer HealthCare has submitted a New Drug Application FDA seeking approval for the oral multi-kinase inhibitor BAY 73-4506 (regorafenib) for the treatment of patients with metastatic Colorectal Cancer (mCRC). The submission is based on the results of a pivotal, global Phase III CORRECT trial which showed an improvement of overall survival of 29% and placebo patients were transferred to regorafenib ...

NovoTTF-100A (NovoCure) shows positive Phase III results for Brain Cancer

A Phase III randomised controlled trial comparing TTFields therapy versus chemotherapy in patients with recurrent Glioblastoma shows that the NovoTTF-100A, from NovoCure, is comparable to chemotherapy in extending overall survival, with minimal side effects and far better quality of life. Patients with a median age of 54 years were randomised to NovoTTF alone or active chemotherapy control. At a median ...

Nexavar (Bayer/Onyx) fails to improve overall survival in MISSION study for NSCLC

Bayer HealthCare and Onyx Pharmaceuticals, announced that the Phase III MISSION trial evaluating Nexavar (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous Non-Small Cell Lung Cancer whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival. An improvement in the secondary endpoint of progression-free survival was observed....

Votrient (Glaxo Smith Kline) prolongs progression-free survival in advanced Soft Tissue Sarcoma

For patients with metastatic Soft Tissue Sarcoma (STS) whose disease has progressed following standard chemotherapy, treatment with Votrient (pazopanib), from Glaxo Smith Kline, nearly tripled progression-free survival compared with placebo, according to results of the PALETTE trial. This is the first time a randomised Phase III trial in metastatic STS has shown improvement in PFS. Of 369 patients enrolled, they ...

Revlimid (Celgene) prolongs disease control for Multiple Myeloma patients

Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with Revlimid (lenalidomide), from Celgene, following a stem cell transplant. A Phase III study, co-authored by Richard Maziarz, M.D., of the OHSU Knight Cancer Institute, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that ...

NICE draft guidance now approves Zytiga (J&J Janssen Cilag) for Prostate Cancer

NICE has issued new draft guidance recommending the use by the NHS of Zytiga (abiraterone acetate), from J&J Janssen Cilag, in patients with Prostate Cancer. After additional information about the drug was submitted to NICE by the company, the treatment will now be made routinely available for patients on the NHS. NICE had previously rejected the drug because it did ...

Phase III study of Torisel (Pfizer) for Renal Cell Carcinoma does not meet primary endpoint

The Phase III INTORSECT (B1771003) study, evaluating Torisel (temsirolimus), from Pfizer, in patients with advanced Renal Cell Carcinoma whose disease had progressed after sunitinib malate therapy, did not meet the primary endpoint of prolonging progression free survival when compared to sorafenib. Although survival was numerically higher in patients treated with temsirolimus, the difference was not statistically significant. Overall survival, a ...

Tivozanib (Astellas) success in TIVO-1 study for Renal Cell Carcinoma

Tivozanib from Astellas/Aveo Pharma is the first treatment to demonstrate greater than one year median PFS in treatment naive patients with metastatic Renal Cell Carcinoma (pre-specified sub-analysis). Treatment with tivozanib resulted in the longest reported median PFS to date in TIVO-1 study, a pivotal study: 12.7 months compared to a median PFS of 9.1 months for sorafenib.( HR = 0.756, ...

Pixuvri (Cell Therapeutics) approved in EU to treat adults with Non-Hodgkin B-Cell Lymphomas

The European Commission has given conditional marketing authorization for Pixuvri (pixantrone), from Cell Therapeutics, as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas. Approval is based on the PIX 301 Phase III trial which demonstrated that a greater proportion of patients achieved a complete response or unconfirmed complete response to Pixuvri than ...

NICE recommends Tarceva (Roche) for NSCLC

NICE has announced that Tarceva (erlotinib) from Roche will join Iressa (geftinib) from AstraZeneca in the UK and Wales as a first line option for patients with locally advanced or metastatic EFGR mutation positive Non Small Cell Lung Cancer....

Iressa (AstraZeneca) is withdrawn from US market for NSCLC

Iressa (gefitinib) from AstraZeneca, was granted accelerated approval by the FDA on 2 May 2003 as monotherapy after failure of both platinum-based and docetaxel chemotherapies for the continued treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer. Postmarketing studies were completed but failed to verify and confirm clinical benefit. The FDA has withdrawn the approval....

Keryx Biopharma returns North American rights to Aeterna Zentaris for perifosine

Keryx BioPharma has returned North American rights to Aeterna Zentaris for the oral anticancer Akt inhibitor, perifosine – a Phase III-stage compound. A Phase III trial called X-PECT evaluating perifosine plus Xeloda (capecitabine) showed a failure to meet the primary endpoint of improving overall survival compared to Xeloda and placebo in the treatment of refractory Colorectal Cancer.The drug remains in ...

FDA Complete Response Letter to Xgeva application to treat high risk Prostate Cancer bone metastases

The FDA has issued a Complete Response Letter for the supplemental Biologics License Application for Xgeva (denosumab) from Amgen to treat men with castration-resistant Prostate Cancer at high risk of developing bone metastases.The Complete Response Letter states that the FDA cannot approve the application in its present form. The FDA determined that the effect on bone metastases-free survival was of ...

FDA approves Votrient (GSK) to treat Soft Tissue Sarcoma

The FDA on 26 April 2012 approved Votrient (pazopanib)from Glaxo Smith Kline to treat patients with advanced Soft Tissue Sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues. A rare cancer with many subtypes, Soft Tissue Sarcoma occurs in about 10,000 cases annually in the United ...

FDA approves Afinitor for treatment of Renal Angiomyolipomas

The FDA has on 26 April 2012 approved Afinitor (everolimus) tablets from Novartis for the treatment of adult patients with kidney tumors known as Renal Angiomyolipomas and Tuberous Sclerosis Complex (TSC), who do not require immediate surgery. This marks the first approval of a medical treatment in this patient population. The accelerated approval was based on the Phase III EXIST-2 ...

New Europe-focused Phase III Trial of TheraSphere (Nordion) for Liver Cancer

A new Phase III clinical trial for TheraSphere, a yttrium-90 (Y-90) glass microsphere treatment for Liver Cancer, from Nordion, will be focused primarily in Europe, with additional locations to be identified globally. This therapy consists of millions of microscopic, radioactive glass microspheres (20–30 micrometres in diameter) that are infused into the arteries that feed liver tumors. These microspheres then embolize, ...

NICE rejects Avastin/Xeloda (Roche) combination for Breast Cancer

NICE does not recommend the use of Avastin (bevacizumab) from Roche in combination with Xeloda (capecitabine) for first line treatment of metastatic Breast Cancer. It has previously refused to recommend Avastin in combination with a taxane for first line treatment. An improvement in overall survival and better quality of life was not clear....

MORAb-004 (Morphotek/Eisai) begins Phase II study in metastatic Colorectal Cancer

A multi-centre Phase II study evaluating the safety and efficacy of MORAb-004, from Morphotek/Eisai, in the treatment of metastatic Colorectal Cancer that is refractory to all standard therapy has begun. The trial is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of single agent MORAb-004 plus best supportive care as determined by progression-free survival in patients with ...

Benefits of Avastin (Roche) for older patients with NSCLC are not clear

Adding Avastin (Roche) to the standard chemotherapy regimen for Non-Small Cell Lung Cancer (NSCLC) – an approach approved by the FDA in 2006 – does not lead to significantly increased survival rates for patients over the age of 65, a new study shows. A previous trial found that adding Avastin to the standard two-drug treatment for NSCLC – the chemotherapy ...

Valeant Pharma to market Halaven for Breast Cancer in Eastern Europe

Valeant Pharma (Swiss division) will distribute Halaven (eribulin) from Eisai in Bulgaria, Estonia, Latvia, Lithuania, Poland, Romania, Hungary and Slovenia for the treatment of patients with metastatic Breast Cancer whose disease has progressed after at least two chemotherapeutic regimens. Halaven is approved in the USA and EU....

BIND-014 first nanomedicine to enter clinical studies

BIND-014 is the first targeted and programmed nanomedicine to enter human clinical studies. The Phase 1 study has been electronically published in Science Translational Medicine. BIND-014 is a programmable nanomedicine that combines a targeting ligand and a therapeutic nanoparticle. BIND-014 contains docetaxel, a proven cancer drug which is approved in major cancer indications including breast, prostate and lung, encapsulated in ...

Entinostat (Syndax/GSK) enetrs Phase I/II trial for Breast Cancer

Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, announced that investigators at The University of Texas MD Anderson Cancer Center Department of Breast Medical Oncology have initiated a phase 1/II study combining entinostat, a benzamide histone deacetylase inhibitor, from Syndax Pharma with lapatinib ditosylate (Tykerb) in patients with locally recurrent or distant relapsed metastatic Breast Cancer previously treated with trastuzumab ...

EOquin (Spectrum/Allergan) Phase III results in Bladder Cancer

Two double blind, randomized, placebo controlled, Phase III clinical trials for EOquin (apaziquone) as a treatment for Bladder Cancer did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between the two arms. However, analysis of the pooled data from both studies showed a statistically significant treatment effect in favor ...

FDA priority review for Zaltrap (Regeneron/Sanofi) for Colorectal Cancer

The FDA has granted priority review of the Biologics License Application for Zaltrap (aflibercept) from Regeneron/Sanofi in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen. A target date for a decision by the agency has been set for August 4. The filing was based on the Phase III VELOUR study ...

Regorafenib (Onyx/Bayer) in Phase GRID study for GIST

Results were announced by Onyx Pharma/Bayer Healthcare from the Phase III trial GRID (GIST - Regorafenib in Progressive Disease) evaluating the investigational compound regorafenib (BAY 73-4506 for the treatment of patients with metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib. The trial met its primary endpoint of statistically ...

Minophagen extends marketing rights to bexarotene for T-Cell Lymphoma

Minophagen Pharma has acquired further rights to market the synthetic retinoid bexarotene from Eisai. Minophagen has added to its rights to market in Japan the territories of Asia, Oceana, the Middle East and Eastern Europe.The drug is marketed in 20 countries for refractory/recurrent T-Cell Lymphoma and in the USA by Eisai as Targretin....

NICE rejects Halaven (Eisai) for Breast Cancer

NICE, the health technology appraisal institute for England and Wales has rejected Halaven (eribulin) from Eisai for locally advanced or metastatic breast cancer in patients whose disease has progressed after at least two chemotherapeutic regimens. The rejection comes after a failed appeal from Eisai against the final draft recommendations. Evidence indicated that Halaven might help some patients live "a little ...

KRX-0401 (Keryx/Aeterna Zentaris) fails X-PECT trial for Colorectal Cancer

Aeterna Zentaris Inc. has announced that the Phase III "X-PECT" (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine + capecitabine (Xeloda) in patients with refractory advanced Colorectal Cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo. The trial involving 468 patients in 65 sites in the U.S was conducted by ...

Farletuzumab (Morphotek) now in Phase III trial for Ovarian Cancer

Morphotek/Eisai has completed enrollment of the FAR-131 clinical trial. The study is a pivotal Phase III randomized trial of Farletuzumab in first-relapsed patients with platinum-sensitive ovarian cancer. Farletuzumab is a humanized monoclonal antibody that targets folate receptor alpha (FRA), which is expressed on the majority of non-mucinous epithelial ovarian cancers as well as a subset of other carcinomas....

IMPACT study for Provenge (Dendreon) effect in Prostate Cancer questioned

Marie Huber in a paper in the Journal of the National Cancer Institute argues that Provenge (sipuleucel-T)from Dendreon extended survival because older men in the IMPACT study who did not receive Provenge died months sooner than similar patients in other studies possibly due to leukapheresis. She argues that the placebo they received was actually harmful making the Provenge effect appear ...

NICE recommends Xgeva (Amgen/GSK) for SRE prevention of Solid Tumors

NICE, The National Institute for Health and Clinical Excellence, has issued draft guidance recommending the use of human monoclonal antibody Xgeva (denosumab) from Amgen/GSK for for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) for those with bone metastasis from breast cancer, patients with painful bone metastasis from hormone-refractory prostate cancer ...

Yervoy (BMS) in Brain Metastases study

Yervoy (ipilimumab) from BMS may help shrink some tumors and may slow progression of secondary tumors in the brain (metastases) in some patients with advanced melanoma. The researchers enrolled 72 patients with brain metastases to participate in the study:Cohort A contained 51 neurologically asymptomatic patients Cohort B contained 21 symptomatic patients receiving corticosteroids for clinical or radiological control of their ...

Genentech reports successful EMILIA study results for T-DMI for HER-2 Breast Cancer

Topline results of EMILIA, the first randomized Phase III study of T-DM1 (trastuzumab emtansine) are announced by Genentech. The study enrolled people with HER2-positive metastatic Breast Cancer (mBC) who had previously received treatment with Herceptin (trastuzumab) and a taxane chemotherapy. The study showed people who received trastuzumab emtansine lived significantly longer without their disease getting worse (progression-free survival, or PFS) ...

JAMA publishes Glivec (Novartis) follow up data in GIST

The Journal of the American Medical Association (JAMA) has published a Phase III study that showed significant survival benefits for patients meeting the study inclusion criteria who received three years of treatment with Glivec (imatinib)from Novartis after surgery to remove KIT (CD117)-positive Gastrointestinal Stromal Tumors (KIT+ GIST) compared to one year of treatment. The study results were first presented at ...

BOLERO-2 trail shows bonbe improvement with Afinitor/Aromasin combination in Breast Cancer

A review of BOLERO-2 Phase III trial in oestrogen receptor positive post menopausal women showed that the combination of Afinitor (everolimus) plus Aromasin (exemestane) significantly improved bone strength and reduced the chance of cancer spreading to the bone. The trial had earlier shown that this drug combination significantly improved outcomes stopping tumour growth for nearly 11 months...

FDA Advisory Committee recommends Marqibo for Ph-ALL

Talon Therapeutics has announced the FDA Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit/risk assessment for use of Marqibo(vincristine sulfate liposomes injection) for the indication for the treatment of adult Philadelphia chromosome-negative (Ph-) Acute Lymphoblastic Leukemia (ALL) in second or greater relapse or that has progressed following ...

Mammaprint genomic test (Agendia) spares Breast Cancer patients chemotherapy with no adverse effect on survival

Testing a Breast Cancer tumour for its genomic signature using the Mammaprint assay, from Agendia, can help identify which patients will need adjuvant systemic therapy (additional chemotherapy) after surgery, and spare its use in those for whom it is not necessary. The researchers studied 427 patients with early Breast Cancer in a study called RASTER. By looking for a particular ...

FDA advisors recommend approval of Votrient (Glaxo Smith Kline) for Soft Tissue Sarcoma

The FDA's Oncologic Drugs Advisory Committee voted to support use of Votrient (pazopanib), from Glaxo Smith Kline, for patients with advanced Soft Tissue Sarcoma who have received prior chemotherapy. Data from a 369-patient study showed the drug enabled patients to live a median of 4.6 months, about 3.1 months longer than placebo, without disease progression. The trial excluded patients with ...

FDA advisors vote against Taltorvic (Merck/Ariad) for Sarcoma patients

The FDA's ODAC voted 13-1 against the use of Taltorvic (ridaforolimus), from Merck / Ariad, as maintenance therapy for patients with metastatic soft-tissue Sarcoma or Bone Sarcoma whose disease has not progressed after at least four cycles of chemotherapy. This was based on data showing patients on Taltorvic had a median progression-free survival of 17.7 weeks compared with 14.6 weeks ...

NICE recommends Tasigna (Novartis) for CML

In final draft guidance, NICE has recommended Tasigna (nilotinib), from Novartis, for CML. The decision is not based on direct data. The independent appraisal committee concluded from indirect comparisons that the drug is effective in treating CML. The panel found that the most plausible Incremental Cost-effectiveness Ratio (ICER) for Tasigna compared with standard-dose Glivec was considered to be £11,000 per ...

NICE does not recommend Sprycel (BMS) for CML

In final draft guidance, NICE has not recommended Sprycel (dasatinib), from BMS, as first-line treatment of Chronic Myeloid Leukaemia. The panel found that the most plausible Incremental Cost-effectiveness Ratio (ICER) for Sprycel compared with standard-dose Glivec exceeded £200,000 per QALY gained....

ALLEGRO trial of laquinimod reported in NEJM

Teva/Active Biotech have announced the publication of results from the laquinimod Phase III ALLEGRO study in the March 15 issue of The New England Journal of Medicine. Data from the two-year study showed that oral once-daily laquinimod reduced inflammatory disease activity as measured by clinical relapses and Magnetic Resonance Imaging (MRI), slowed disability progression and decreased brain tissue loss, while ...

FDA approves first generic Lexapro for Depression and Anxiety Disorder

The FDA has approved the first generic version of Lexapro (escitalopram tablets) to treat Depression and generalised Anxiety Disorder in adults. The generic is produced by Teva Pharmaceutical Industries/IVAX Pharmaceuticals who will be marketing generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths. Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA ...

APG101 (Apogenix) meets primary endpoint in Phase II trial for Glioblastoma Multiforme

The Phase II clinical efficacy trial with APG101, from Apogenix, has met its primary endpoint in the 2nd line treatment of a common form of Brain Cancer, Glioblastoma Multiforme (GBM), following a six month follow up of the last patient treated. The primary endpoint of the trial was the six-month-rate of progression-free survival (PFS6) and secondary endpoints include overall survival ...

Phase III study of Zytiga (Janssen) for Prostate Cancer unblinded

A Phase III study of Zytiga (abiraterone acetate), from Janssen, plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant Prostate Cancer (CRPC) has been unblinded. Study COU-AA-302 is an international, placebo controlled study that included 1,088 patients randomised to receive Zytiga (1,000 milligrams) once daily plus prednisone 5 mg twice daily or placebo plus prednisone ...

FDA approves Inform HER2 Dual ISH DNA Probe cocktail assay (Ventana MS) as Breast Cancer assay

The FDA has approved the Inform HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH), from Ventana Medical Systems, for use on the Ventana BenchMark ULTRA automated slide staining platform. It was originally approved by the FDA in June 2011 for use with the BenchMark XT instrument. The Inform HER2 Dual ISH assay is intended for use in the ...

CT colonography shown to be comparable to standard colonoscopy

Computerized tomographic colonography (CTC), also known as virtual colonoscopy, is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps in people ages 65 and older. This is consistent with results of the ACRIN National CT colonography Trial, published in the New England Journal of Medicine in 2008, which demonstrated CT colonography can serve as a ...

FDA approves C20 Invendoscope (Invendo Medical)

The FDA has provided 501(K) approval for the new C20 Invendoscope colonoscopy system including the SC20 single-use colonoscope, from Invendo Medical. This device is not pushed or pulled, but uses a computer-assisted gentle drive technology to move through the colon. This reduces forces on the colon wall. The C20 is a fully integrated unit with positioning arm attached to a ...

TH-302 (Threshold/Merck Serono) success in Phase IIb Pancreatic Cancer trial

TH-302 a hypoxia targetted drug from Threshold Pharma/Merck Serono has produced a significant 63% extension in progression-free survival in a Phase IIb study in Pancreatic Cancer. The pancreatic cancer study combined TH-302 with gemcitabine for first-line treatment of advanced disease, with a primary endpoint of progression-free survival (PFS). The primary efficacy analysis performed on 149 patients showed median PFS of ...

Enrollment complete for Phase III Carfilzomib (Onyx Pharmaceuticals) trial for Multiple Myeloma

The Phase III ASPIRE trial evaluating carfilzomib, from Onyx Pharmaceuticals, in combination with Revlimid (lenalidomide) and low dose dexamethasone in patients with relapsed Multiple Myeloma has reached its target enrollment figures of 780 patients and is being conducted at approximately 200 sites in North America, Europe, and Israel. The FDA is currently reviewing a New Drug Application for potential accelerated ...

European Commission approves Caprelsa(AstraZeneca) for medullary Thyroid Cancer

The European Commission has granted marketing authorisation for Caprelsa (vandetanib) for the treatment of aggressive and symptomatic medullary Thyroid Cancer in patients with unresectable locally advanced or metastatic disease. Caprelsa is the first approved treatment for advanced medullary Thyroid Cancer in Europe. Caprelsa was granted orphan drug status and approved by the FDA in April 2011. Caprelsa is also approved ...

Brivanib (BMS) fails in Phase III Colorectal Cancer Trial

According to a National Cancer Institute of Canada and Australasian Gastro-Intestinal Trials Group CO.20 Phase III study, overall survival was no better for advanced Colorectal Cancer patients with KRAS-normal tumors treated with brivanib alaninate, from BMS, plus cetuximab than for those treated with cetuximab alone. Although the combination appeared to improve response rates and progression-free survival, suggesting that brivanib may ...

CHMP recommends Pixuvri (CTI Life Sciences) for Non Hodgkin's B-cell Lymphoma

The CHMP has given a conditional recommendation for the approval of Pixuvri (pixantrone dimaleate) from CTI Life Sciences for relapsed or refractory aggressive non-Hodgkin’s B-cell Lymphoma. The drug application at the FDA was withdrawn as additional information was requested. The drug is now scheduled to be considered at the FDA Advisory Comitteee meeting in April 2012....

NICE rejects Tyverb (GSK) as first line treatment of Post Menopausal Breast Cancer

NICE finds that the overall survival benefit of Tyverb (lapatinib) from GSK, alongside aromatase inhibitors, as first line treatment for post menopausal breast cancer patients whose disease has spread is of small effect and uncertain and not cost effective....

NICE rejects Herceptin (Roche) as first line treatment for Post Menopausal Breast Cancer

NICE finds that the overall survival benefit of Herceptin (trastuzumab)from Roche/Genentech, alongside aromatase inhibitors as first line treatment for post menopausal breast cancer patients whose disease has spread is of small effect and uncertain and not cost effective....

Phase III Trial of MDV 3100 (Medivation/Astellas) in Prostate Cancer patients shows positive results

Researchers have presented positive results on all efficacy endpoints from the Phase III AFFIRM trial of the investigational drug MDV 3100, from Medivation and Astellas, in men with Prostate Cancer previously treated with chemotherapy. The results, presented at the 2012 Genitourinary Cancers Symposium, show that men taking MDV 3100 lived for a median of 18.4 months, compared with 13.6 months ...

Erivedge (Genentech/Roche)is FDA approved for Basal Cell Carcinoma

The FDA has approved Erivedge (vismodegib) from Genentech/Roche to treat adult patients with Basal Cell Carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced Basal Cell Cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic). Erivedge, ...

Pfizer files bosutinib at FDA for PH+CML

The FDA has accepted its New Drug Application (NDA) for standard review of bosutinib, a once a day oral dual Src and Abl kinase inhibitor from Pfizer, as a treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). This submission was based on efficacy and safety data from Study 200, a single-arm study ...

FDA approves Inlyta (Pfizer) for Renal Cell Carcinoma

The FDA has approved Inlyta (axitinib)from Pfizer to treat patients with advanced kidney cancer (Renal Cell Carcinoma) who have not responded to another drug for this type of cancer. The decision was based on the AXIS 1032 study where axitinib significantly extended progression-free survival (PFS), with a median PFS of 6.7 months (95% CI, 6.3-8.6 months), compared with 4.7 months ...

Afatinib(Boehringer) enters Phase III trials for Head and Neck Cancer

Afatinib from Boehringer enters Phase III trials for Head and Neck cancer.LUX-Head & Neck 1 and LUX-Head & Neck 2. These trials evaluate Afatinib in patients with metastatic and recurrent head and neck cancer, and in patients with locally advanced disease, respectively....

Spectrum Pharma acquires world rights to Zevalin for NHL

Spectrum Pharmaceuticals will acquire from Bayer Healthcare the licensing rights to market Zevalin (ibritumomab tiuxetan) injection for intravenous use for the non-Hodgkin's lymphoma treatment outside the USA. Spectrum already has the rights to market the drug in the USA and will now hold the worldwide rights to Zevalin. The product is currently approved in more than 40 countries outside the ...

Picato (Leo Pharma) is FDA approved for Actinic Keratosis

The FDA has approved Picato (ingenol mebutate) gel in the 0.015%/0.05% strength from Leo Pharma for the topical treatment of Actinic Keratosis which is a precancerous condition resulting from cumulative sun exposure that has the potential to lead to squamous cell carcinoma. The drug is the first and only topical therapy available in the USA for Actinic Keratosis that can ...

Afinitor (Novartis) fails Gastric Cancer study

Novartis reported the results of the 656 patient GRANITE-1 Phase III randomised, double-blind, multicentre study which showed that Afinitor (everolimus) monotherapy did not significantly improve overall survival in patients with advanced Gastric Cancer who had previously been treated with one or two lines of systemic chemotherapy....

Eloxatin (Sanofi) improves Colon Cancer survival

Stage III Colon Cancer patients in the general population who receive adjuvant treatment for the disease have an improved rate of survival when Eloxatin (oxaliplatin) is added to 5-fluorouracil. It's known that adding Eloxatin to adjuvant 5FU improve outcomes of patients with stage III Colon Cancer in randomised clinical trials (RCTs) but the effect of this therapy outside RCTs is ...

CHMP rejects Folotyn (AllosTherapeutics and Mundipharma) for T-Cell Lymphoma

The CHMP adopted a negative opinion, recommending the refusal of marketing authorisation for the medicinal product Folotyn,(pralatrexate injection), from Allos Therapeutics, intended for the treatment of peripheral T-cell Lymphoma. The CHMP was concerned that the main study was designed in a way that did not allow the Committee to assess the benefit of the medicine, particularly since Folotyn was not ...

Bayer HealthCare plans to file regorafenib at the FDA for Metastatic Colorectal Cancer in 2012

The 760 patient CORRECT trial of the oral multikinase inhibitor, regorafenib, from Bayer Healthcare was halted for the treatment of Metastatic Colorectal Cancer after showing an improvement of overall survival of 29% and placebo patients were transferred to regorafenib therapy. Bayer now reports that patients on regorafenib therapy lived 6.4 months longer compared with 5 months for those on placebo. ...

Combining 2 anti-HER2 drugs may provide better preoperative breast cancer treatment

Adding Tyverb/Tykerb(lapatinib), from Glaxo Smith Kline, to Herceptin (trastuzumab) was more effective than single-drug treatment with either drug in eliminating microscopic signs of early-stage HER2-positive Breast Cancer at the time the tumors were surgically removed. The 455 patients in the NeoALTTO study were given anti-HER2 treatment with either intravenous trastuzumab, oral lapatinib or both for 6 weeks. Tumors were removed ...

Zytiga (J&J Janssen Cilag) offers benefits for Prostate Cancer patients who are not eligible for docetaxel therapy

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has noted a considerable added benefit of Zytiga (abiraterone acetate), from J&J Janssen Cilag, in patients with metastatic hormone-refractory Prostate Cancer who are not eligible for further treatment with docetaxel. Zytiga has been approved since September 2011 for men with metastatic Prostate Cancer that ...

Nexavar (Bayer HealthCare) effective in patients with Non-Small Cell Lung Cancer

Nexavar (sorafenib tosylate), from Bayer HealthCare, was effective in patients with Non-Small Cell Lung Cancer and a KRAS mutation, but survival rates were reportedly "unsatisfactory," according to data presented at the AACR-IASLC Joint Conference on Molecular Origins of Lung Cancer: Biology, Therapy and Personalized Medicine. In the Phase II study, researchers assigned 57 patients with NSCLC and a KRAS mutation ...

FDA to review Xgeva(Amgen) potential to delay bone metastases in non-metastatic Prostate Cancer

The FDA has invited Amgen to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases. The review results from clinical studies in support of this new indication, including ...

Olaparib (AstraZeneca)will not proceed to Phase III in Ovarian Cancer

AstraZenenca announced that Olaparib will not progress into Phase III development for the maintenance treatment of serious Ovarian Cancer. The decision to discontinue olaparib’s development in Ovarian Cancer was made following a review of an interim analysis of a Phase II study (study 19) which indicated that the previously reported progression free survival benefit is unlikely to translate into an ...

FDA Approves 's Cervista HTA System (Hologic) for Cervical Cancer screening

The FDA has approved the Cervista HTA (high throughput automation) system, from Hologic Inc, for use with the company's previously approved Cervista human papillomavirus (HPV) HR test. The Cervista HPV HR test utilizes Hologic's Invader technology to detect 14 high risk types of HPV that are associated with Cervical Cancer and precancerous lesions. The Cervista HTA system automates the DNA ...

Avastin (Roche/Genentech) prevents spread of Nasopharyngeal Carcinoma in Phase II trial

Combining Avastin (bevacizumab), from Roche/Genentech, with standard chemoradiation therapy is safe and could prolong survival in patients with advanced Nasopharyngeal Carcinoma, according to a new Phase II trial. The results indicate that Avastin might be more effective at preventing the spread of Nasopharyngeal Carcinoma to other parts of the body, the most common cause of death in patients with advanced ...

Zolinza(Merck Inc.) success in Multiple Myeloma trial

A Phase III study investigating Zolinza (vorinostat) from Merck Inc., in combination with bortezomib, in patients with progressive Multiple Myeloma has met its primary endpoint of improved progression-free survival (PFS) in patients with relapsed and/or refractory forms of the disease.The Phase III results from VANTAGE 088 study were presented at the 53rd Annual Meeting of the American Society of Hematology ...

Zolinza (Merck) shows good response with AML patients

Adding Zolinza (vorinostat), from Merck, a histone deacetylase inhibitor that activates genes to frontline combination therapy for Acute Myeloid Leukemia resulted in an 85 percent remission rate after initial treatment. Seventy five patients in a Phase II study received Zolinza, in addition to the chemotherapy drug cytarabine and idarubicin, an anthracycline antibiotic commonly used as chemotherapy. Zolinza activates suppressed genes ...

ENEST studies of Tasgina (Novartis)show superiority to Glivec in PH+CML

ENESTcmr study is the first exploratory randomized trial to investigate the impact of switching adult patients with residual disease after a minimum of two years of treatment with Glivec imatinib)from Novartis to Tasigna (nilotinib)from Novartis to determine if a deeper level of response could be achieved. The study showed that twice as many patients switched to Tasigna 400 mg twice ...

Herceptin (Roche) may equalise DFS for obese and normal weight Breast Cancer patients

Obese patients with HER2-positive Breast Cancer have larger tumours, increased lymph node involvement and, when not treated with Herceptin (trastuzumab), from Roche, poorer long-term outcomes than normal-weight patients. The study, known as N9831, included 3,017 patients and was the first to explore the relationship between body mass and the patient's response to treatment and disease-free survival (DFS). Patients were assigned ...

Omnitarg (Genentech/Roche ) success in CLEOPATRA trial in untreated HER-2 positive Breast Cancer

The CLEOPATRA study enrolled 808 patients with previously untreated HER2-positive metastatic breast cancer. Patients receiving Omnitarg (pertuzumab), from Genentech/Roche, on top of the current standard treatment combination of trastuzumab (Herceptin) and docetaxel showed a median progression-free survival of 18.5 months, compared with 12.4 months for patients receiving Herceptin and docetaxel alone (hazard ratio 0.62, 95% CI 0.51-0.75, p<0.0001). This increase ...

Why women with Breast Cancer quit aromatase therapy

Just over a third of postmenopausal women who are treated for estrogen-sensitive Breast Cancer using drugs such as Arimidex (anastrozole), from AstraZeneca, and Aromasin (exemestane), from Pfizer, that help prevent the disease from recurring, quit early (before an average of 4.1 years) because of the medications’ side effects, which are more severe and widespread than previously known. Clinicians consistently underestimate ...

Zometa (Novartis) shows clear benefits for premenopausal ER-Positive Breast Cancer patients

A new study of Zometa (zoledronic acid), from Novartis, for Breast Cancer reveals that Zometa and endocrine treatment reduce death risk by 36%, but also that the risk of recurrence drops 28% for patients with early-stage, premenopausal ER-positive Breast Cancer. Data from the ABCSG-12 trial, reported at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, confirmed and extended data reported ...

Aromasin (Pfizer) found to lower 'good' cholesterol levels in Breast Cancer patients

Aromasin (exemestane), from Pfizer, steadily lowered levels of "good" cholesterol in women taking the agent as part of a Breast Cancer prevention study, say researchers at Georgetown Lombardi Comprehensive Cancer Center who presented results at the CTRC-AACR San Antonio Breast Cancer Symposium. They suggest that the effect this agent has on blood lipids may prove to be significant for women ...

Zometa (Novartis) with endocrine therapy improves survival in post menopausal Breast Cancer patients

Adding Zometa (zoledronic acid), from Novartis, to adjuvant endocrine therapy increased bone mineral density and reduced the risk for disease recurrence among postmenopausal women with early hormone receptor-positive Breast Cancer, according to new data from the ZO-FAST trial. Researchers randomly assigned 1,065 patients who were about to commence letrozole, an aromatase inhibitor, to receive immediate Zometa every six months or ...

Tyverb (GSK) disappoints in HER2 positive Breast Cancer

GSK presented results from the TEACH study to the 2011 CRTC-AACR San Antonio Breast Cancer Symposium. TEACH is a randomised, double-blind, placebo-controlled Phase III trial to evaluate the effects of Tyverb/Tykerb ( lapatinib )monotherapy when given to women who were diagnosed with HER2 positive breast cancer. The primary objective of the study was to compare disease-free survival (DFS) between women ...

Addition of Avastin (Genentech) to conventional therapy improves survival in HER2-positive Breast Cancer

An independent review committee has revealed that the addition of Avastin (bevacizumab), from Genentech/Roche, to trastuzumab and docetaxel significantly improved progression-free survival in HER2-positive Breast Cancer, despite findings from an investigator assessment that the improvement was present but statistically non-significant. Results from AVEREL, a 426-patient Phase III trial designed to evaluate the drug combination as first-line therapy for HER2-positive, locally ...

Exemestane plus Afinitor (Novartis) increased progression-free survival for Breast Cancer patients

Afinitor (everolimus), from Novartis, in combination with exemestane has shown promise for the treatment of Breast Cancer, according to a new analysis of the BOLERO-2, Phase III clinical trial, presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. Results revealed a median progression-free interval of 3.2 months for 239 patients treated with exemestane plus placebo. Among the 485 patients ...

Brachytherapy associated with twofold increased risk for Mastectomy

Compared with women treated with whole-breast irradiation, those treated with brachytherapy experienced a twofold increased risk for losing their breasts, according to results at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. The study evaluated the Medicare claims of all U.S. female beneficiaries (n=130,535) aged older than 66 years diagnosed with incident-invasive Breast Cancer between 2000 and 2007. Patients were ...

FDA Advisory Committee recommends Inlyta (Pfizer) for Renal Cell Carcinoma

The FDA Oncologic Drugs Advisory Committee (ODAC) voted unanimously 13 to 0 that data for the investigational agent Inlyta (axitinib), the vascular endothelial growth factor (VEGF) receptor inhibitor from Pfizer, support a favorable benefit/risk profile for the treatment of patients with advanced Renal Cell Carcinoma (RCC) after failure of a first-line systemic therapy. The ODAC panel members reviewed data on ...

Omnitarg (Genentech/Roche) success in Phase II Breast Cancer trial in combination with Herceptin and chemotherapy

In the Phase II NEOSPHERE study, published Online First in The Lancet Oncology, the addition of monoclonal antibody Omnitarg (pertuzumab) from Genentech/Roche, to standard therapy (trastuzumab (Herceptin) plus the chemotherapy drug docetaxel) for women with HER2-positive Breast Cancer improved the rate of complete tumor disappearance by over half after just four cycles, i.e. 12 weeks of treatment compared with the ...

Pixuvri (CellTherapeutics) is refiled at the FDA for NHL

The FDA has accepted the resubmission of Pixuvri(pixantrone dimaleate) from Cell Therapeutics as a single-agent treatment of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.The FDA has not required an additional trial. The FDA has set 24 April 2012 as the new Prescription Drug User Fee Act action date. ...

Cobas EGFR Mutation test (Roche) receives CE mark for NSCLC testing

The Cobas EGFR Mutation Test, from Roche, is now CE marked for commercial availability in Europe and other countries that recognise CE mark. The Cobas EGFR Mutation Test is a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who harbour mutations in the EGFR (epidermal growth factor receptor) gene and who may benefit from treatment with anti-EGFR ...

Onyx Pharma files carfilzomib at the FDA for Multiple Myeloma

The FDA has accepted a new drug application for carfilzomib from Onyx Pharmaceuticals. Onyx is seeking accelerated approval of carfilzomib, a next-generation proteasome inhibitor, as a treatment for patients with relapsed and refractory Multiple Myeloma. The application will be supported by progression-free survival data from the randomized controlled carfilzomib Phase III ASPIRE trial in relapsed multiple myeloma anticipated in early ...

Cobas HPV test (Roche) offers sensitive primary screening strategy for cervical cancer

A sub-analysis of the ATHENA study demonstrates that the Cobas HPV Test, from Roche, could be used for the primary screening of Cervical Cancer. The data, published recently in The Lancet Oncology also showed that identifying women with HPV 16 and/or 18, the two genotypes detected in approximately 70 per cent of Cervical Cancers, provided important predictive information to determine ...

NovoTTF-100A (NovoCure) therapy achieves encouraging long term survival time for Glioblastoma patients

Results from a Phase III EF-11 study comparing overall survival at two and three years after initiating therapy in patients with recurrent glioblastoma multiforme (GBM) treated with NovoTTF-100A therapy, from NovoCure, versus standard chemotherapy show they remain consistent with one-year survival data. With a median follow-up of 39 months, overall survival in the TTF group compared to the chemotherapy group ...

FDA agrees to new labelling of Zevalin (Spectrum Pharma) to remove bioscan Indium 111

The FDA has agreed that Spectrum Pharma can remove from the labelling of Zevalin (ibritumomab tiuxetan) a requirement for a certain type of bioscan, known as an Indium-111 pretreatment imaging evaluation.Patients undergoing treatment with Zevalin no longer need to be exposed to unnecessary radiation with Indium-111. Zevalin is approved in the USA and EU for Follicular Non Hodgkins Lymphoma. Marketing ...

FDA approves BSD-2000 (BSD) for use with Cervical Cancer treatment

The FDA has given Humanitarian Device Exemption (HDE) marketing approval for the BSD-2000 Hyperthermia System, from BSD Medical Corporation, for use in conjunction with radiation therapy for the treatment of Cervical Cancer patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors. The HDE approval authorizes the commercial sale ...

CHMP recommends extension of Erbitux (Merck Serono) indication in Colorectal Cancer

The CHMP recommends extension of the label for Erbitux (cetuximab) from Merck Serono/BMS for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic Colorectal Cancer as first in line therapy with the FOLFOX chemotherapy in addition to its use in combination with irenotecan-based chemotherapy....

Erwinase (EUSA) is FDA approved for acute lymphoblastic leukemia

The FDA on 18 November 2011 has approved Erwinase from EUSA Pharma as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.Erwinase is currently approved in a number of countries, including Canada, the UK and several European Union member states.Many children with ALL develop ...

FDA withdraws approval of Avastin (Genentech) for Breast Cancer patients

The FDA has revoked the agency’s accelerated approval of the Breast Cancer indication for Avastin (bevacizumab), from Genentech. According to the FDA, Avastin has not shown benefit for delaying the growth of tumours in patients with metastatic Breast Cancer and thus cannot justify its costs and serious and potentially life-threatening risks. Nor is there evidence that use of Avastin helps ...

Reolysin (Oncolytics) success in Head and Neck Cancer

A trial called, REO 015, was a single arm open-label, study of Reolysin, from Oncyolytics Biotech, which was given intravenously with paclitaxel (175 mg/m2) and carboplatin (AUC 5) every three weeks in patients with platinum-refractory recurrent and/or metastatic squamous cell cancers of the oral cavity, larynx, or pharynx. Findings were presented at the AACR-NCI-EORTC International Conference on Molecular and Cancer ...

CHMP recommends Caprelsa (AstraZeneca) for Thyroid Cancer

The CHMP has recommended vandetanib, as Caprelsa from AstraZeneca for the treatment of advanced, aggressive and symptomatic medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease, a rare form thyroid cancer. Previously the drug was known as Zactima. The drug has been approved by the FDA and the decision was based on the ZETA study....

Xgeva results of '147' trial prevention of bone metastases in Prostate Cancer is published in The Lancet

The'147' Phase III study of Xgeva (denosumab)from Amgen/GSK ) evaluated Xgeva for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer and is published in The Lancet. The study found Xgeva significantly prolonged bone metastasis-free survival, delayed time to bone metastasis and reduced the risk of symptomatic bone metastases. This study is ...

Studies show Cervarix (GlaxoSmithKline) protects against serious precursor to invasive Cervical Cancer

Two studies show the human papillomavirus (HPV) vaccine Cervarix (papillomarvirus vaccine), from GlaxoSmithKline, offers excellent protection against the more serious immediate precursor to invasive Cervical Cancer (ICC), particularly when given to young adolescent girls before they become sexually active. They also show that the vaccine partially protects against four other cancer-causing HPV types not targeted by the formulation, that together ...

FDA to review vismodegib(Genentech) for Basal Cell Carcinoma

The FDA will review vismodegib from Genentech/Roche, being the first-in-class oral treatment that inhibits signalling in the Hedgehog pathway which is implicated in more than 90% of Basal Cell Carcinoma cases.The FDA review is planned to take place on 8 March 2012. The filing is supported by the ERIVANCE BCC study....

FDA approves Erbitux (BMS/Merck-Serono) for metastatic Head and Neck Cancer

The FDA has approved Erbitux (cetuximab), from BMS/Merck-Serono, in combination with platinum-based chemotherapy with 5-fluorouracil, for the first-line treatment of recurrent locoregional or metastatic Head and Neck cancer. The drug is already FDA approved for some colon cancers and non-metastatic Head and Neck Cancer. The latest approval is based on data from the Phase III EXTREME trial which showed that ...

Radiotherapy combined with androgen deprivation therapy improves survival in Prostate Cancer patients

Men with locally advanced Prostate Cancer and who receive radiotherapy (RT) on top of their androgen deprivation therapy (ADT) using treatments such as leuprolide acetate have greater overall survival compared with men on ADT alone. This trial followed 1205 patients were randomly assigned to either ADT and RT or ADT alone. The addition of RT to ADT improved overall survival ...

Velcade (Millennium/Janssen Cilag) success in Multiple Myeloma trial

The VISTA trial, compared Velcade, from Millennium and Janssen Cilag, with the established standard of care therapy in 682 patients with previously untreated multiple myeloma. The data showed that patients treated with Velcade, melphalan and prednisone continued to have a statistically significantly longer overall survival than patients treated only with melphalan and prednisone (56.4 versus 43.1 months, p<0.05). The complete ...

Phase III trial of MDV 3100 (Medivation/Astellas) shows significant benefits for patients with advanced Prostate Cancer

An analysis of a Phase III trial of men with advanced Prostate Cancer treated using MDV 3100, from Medivation and Astellas, shows the AFFIRM trial has met its interim efficacy stopping criteria by demonstrating a statistically significant improvement in survival. Those on the drug outlived those on placebo by an average of 4.8 months, and the trial has been stopped ...

Erbitux (Merck Serono/BMS) effective in NSCLC patients with EGFR mutation

Patients with the most common form of Non-Small Cell Lung Cancer whose tumours express high levels of epidermal growth factor receptor (EGFR) are more likely to benefit from treatment with Erbitux (cetuximab), from ImClone /BMS/ Merck-Serono, and live longer compared with those given chemotherapy alone. The findings suggest that testing for level of EGFR expression could be used in everyday ...

Actos improves efficacy of radioiodine therapy in Metastatic Thyroid Cancer

A new study of the effectiveness of Actos(pioglitazone), from Takeda, given prior to radioiodine therapy in patients with Metastatic Thyroid Cancer suggests the drug can enhance the effectiveness of the radiotherapy when repeated. Usually, repeated radio-ablation therapy with iodine-131 to treat Metastatic Thyroid Cancer can be less effective than the initial treatment round due to de-differentiation of the cancer cells ...

Switching from tamoxifen to Aromasin improves Breast Cancer survival rate

Changing to Aromasin (exemestane), from Pfizer, after two to three years of tamoxifen treatment can cut women's risk of dying from Breast Cancer, according to new data. The study, led by Professor Judith Bliss, Director of the Institute of Cancer Research’s Clinical Trials & Statistics Unit, examines the effectiveness of switching to Aromasin after two to three years tamoxifen to ...

EU approves Alimta as continuation maintenance therapy in non squamous NSCLC

The European Commission has granted approval for the use of Alimta (pemetrexed for injection) from Eli Lilly as a single agent for continuation maintenance therapy in patients with a particular type of lung cancer, called advanced nonsquamous non-small cell lung cancer (NSCLC). The approval is based on clinical trial results showing an improvement in progression-free survival, as well as a ...

NICE recommends Mepact for Osteosarcoma

NICE,the health technology appraisal institute for England and Wales, has published final guidance recommending Mepact (mifamurtide)from Takeda in combination with post-operative multi-agent chemotherapy as an option for treating high-grade resectable non-metastatic osteosarcoma in children, adolescents and young adults. This was a reversal of an earlier decision....

CORRECT trial for regorafenib success in Colorectal Cancer

Positive results are announced from the Phase III CORRECT trial of regorafenib ,a multi kinase inhibitor,from Bayer Healthcare, for the treatment of Metastatic Colorectal Cancer in patients whose disease has progressed after standard therapies. The Data Monitoring Committee has halted the study and placebo patients were transferred to regorafenib therapy. The trial met its primary endpoint of statistically significantly improving ...

Ameluz has CHMP recommendation for Actinic Keratosis

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Ameluz (5-aminolevulinic acid) from Biofrontera AG for the treatment of actinic keratosis....

Femara offers significant advantages over tamoxifen for Breast Cancer patients

New results of a 12-year study suggest that treatment with Femara (letrozole), from Novartis, offers lower recurrence rates and significantly improved long-term survival time for women with hormone receptor-positive early Breast Cancer compared to tamoxifen therapy. According to the study's lead author, Meredith Regan from the Dana-Farber Cancer Institute in Boston, women given Femara monotherapy after surgery for five years ...

TG 4010 combination raises progression free survival in Non Small Cell Lung Cancer patients

Results published in The Lancet Oncology suggest that a combination of chemotherapy and an experimental vaccine called TG4010, from Transgene, results in significantly more progression free survival in patients with advanced Non Small Cell Lung Cancer compared to those on chemotherapy alone. In this the Phase II trial, led by Elisabeth Quoix from the Université de Strasbourg in Strasbourg, France, ...

Subcutaneous Herceptin trial reveals benefits for Breast Cancer patients

Women with HER2-positive early Breast Cancer treated with a new, investigational subcutaneous (SC) injection of Herceptin (trastuzumab), from Roche, experienced comparable results to those given Herceptin as an intravenous (IV) infusion, according to new results from a Phase III study. According to results of the HannaH trial involving 596 women, the SC administration takes around 5 minutes to administer whereas ...

China's FDA approves PCR KRAS Assay For Colorectal Cancer

China's State Food and Drug Administration has approved China Medical technologies real-time PCR-based V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) assay as a companion diagnostic test for the use of a targeted drug for the treatment of Colorectal Cancer patients. The PCR KRAS Assay is a diagnostic test used to detect specific mutations in the KRAS gene using a ...

SiMoA PSA test found a reliable predictor of Prostate Cancer recurrence

A clinical evaluation of the SiMoA Prostate Specific Antigen (PSA) test, from Quanterix, shows that this digital immunoassay is a reliable predictor of five–year biochemical recurrence (BCR)–free survival following radical prostatectomy (RP) in patients with Prostate Cancer. To determine the ability of this test to predict five–year BCR–free survival following RP, researchers utilized frozen serum specimens from men who had ...

FDA warns that Leukemia drug Sprycel can lead to PAH

The FDA has issued a warning that treatment with Sprycel (dasatinib), from BMS, may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs, called pulmonary arterial hypertension (PAH). With PAH, the heart must work harder to pump the blood into the lungs and the overworked heart ...

MabCampath/Campath plus fludarabine offers improved treatment for CLL

A new study shows that combining the chemotherapy drug fludarabine with the monoclonal antibody MabCampath/Campath(alemtuzumab), from Genzyme, significantly increases progression free survival (PFS) and prolongs the lives of patients who have relapsed with the most common type of leukaemia, chronic lymphocytic leukaemia (CLL), compared with fludarabine alone. The findings suggest that this new drug combination could be a less toxic ...

Zometa prevents bone loss side effects of Breast Cancer medication

The Osteoporosis drug Zometa (zoledronic acid), from Novartis, appears to protect against the bone damaging side effects of certain Breast Cancer medications, according to results in the journal Cancer. Many postmenopausal women with Breast Cancer are treated for several years with aromatase inhibitors, but as a side effect, these agents can cause bone loss and fractures. So a five-year study, ...

Merck Inc. files ridaforolimus at FDA for Metastatic Sarcomas

Merck Inc. has filed ridaforolimus at the FDA seeking approval of the drug as a treatment for patients with metastatic soft tissue or bone Sarcomas. There have been no new treatments in the US for sarcomas in 20 years. The application is based on results of the SUCCEED trial....

Velcade withdrawn from combination treatment of Follicular Lymphoma

Millennium Pharma, the subsidiary of Takeda specialising in oncology, will withdraw its supplemental new drug application to the FDA seeking a new use of Velcade (bortezomib) in combination with Rituxan (rituximab) from Genentech/Biogen Idec as a treatment for patients with relapsed follicular lymphoma....

Resection with Erbitux boosts survival in Colorectal Cancer patients with Liver Metastases

Adding Erbitux (cetuximab)from Merck Serono/BMS, to conventional chemotherapy improves overall survival (OS) in Colorectal Cancer patients with complete resection of liver metastases that were initially deemed inoperable. The results, presented at the 2011 European Multidisciplinary Cancer Congress, were based on a 110-patient CELIM study which randomised patients to Erbitux plus FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or Erbitux plus FOLFIRI (leucovorin, ...

Puma Biotechnology licenses neratinib for Breast Cancer from Pfizer

Pfizer has granted a worldwide licence of neratinib, its Phase-III oral tyrosine kinase inhibitor, to Puma Biotechnology. Neratinib is a novel treatment of Breast Cancer being an inhibitor of the ErbB1 (EGFR), ErbB2 (HER2) and ErbB4 (HER4) kinases....

FDA issues warnings on Avastin

The FDA has issued new warnings concerning Avastin (bevacizumab) from Genentech/Roche, in relation to ovarian failure, osteo-necrosis of the jaw and venous thromboembolism ,including bleeding. These warnings have been added to the US label. The FDA has also indicated thea it is likely to remove the breast cancer indication of the drug....

Hologic presents its MammoSite ML for Radiation Therapy

Hologic featured its next-generation MammoSite ML (multi-lumen) radiation therapy system at the American Society of Radiation Oncology (ASTRO) meeting. By employing the MammoSite system, the radiation oncologist can deliver targeted radiation therapy directly to the area where cancer is most likely to recur, allowing a full course of radiation to be delivered in just five days. Additionally, targeted therapy of ...

Early stage Breast Cancer benefit from Herceptin and chemotherapy

Treating women with early stage Breast Cancer using a combination of chemotherapy and the molecularly targeted drug Herceptin (trastuzumab), from Genentech, significantly increases survival in patients with a specific genetic mutation (HER-2) that results in very aggressive disease, according to a paper in the New England Journal of Medicine. The three-armed study compared the standard therapy of Adriamycin and Carboplatin ...

Mechlorethamine hydrochloride gel is filed at FDA for Mycosis Fungoides

Yaupon Therapeutics has filed at the FDA an application (NDA) for its gel formulation of mechlorethamine hydrochloride as a topical treatment for early-stage mycosis fungoides, the most common type of cutaneous T-Cell lymphoma (CTCL), a rare form of non-Hodgkin's lymphoma. Mycosis fungoides is the most common type of Cutaneous T-Cell Lymphoma, a rare form of non-Hodgkin's lymphoma. The cause of ...

MedImmune and Pfizer collaborate on anti cancer tremelimumab

Pfizer and MedImmune ( a subsidiary of AstraZeneca) will collaborate to develop tremelimumab. The drug was unsuccessful in a Phase III trial for Melanoma but discovery of a biomarker has spurred development and DebioPharm are running a Phase III trial for treatment of Melanoma.The agreement will give MedImmune global rights for cancer indications and Pfizer will retain rights to certain ...

Adventrx Pharma discontinues Exelbine for Non Small Cell Lung Cancer

Meetings between Adventrx Pharma and the FDA were not productive regarding the FDA Complete Response Letter and Adventrx has decided to focus its capital on its other compounds, ANX-188 and ANX-514, which reflect larger market opportunities. The company will discontinue its Exelbine programme until it finds a partner or outside investor....

Higher radiation dose plus Erbitux not beneficial for Lung Cancer patients

An interim analysis of a Phase III trial to find out if high doses of radiation plus Erbitux (cetuximab), from BMS, increases survival among stage III non-small cell lung cancer patients reveals that a higher dose of radiation (74 Gy) does not improve overall survival for non-small cell lung cancer that has spread to the lymph nodes, compared to the ...

NICE rejects Jevtana for Prostate Cancer

NICE, the health technology appraisal institute for England and Wales, has issued draft guidance declining to recommend Jevtana (cabazitaxel) from Sanofi-Aventis for prostate cancer patients already treated with Taxotere ( docetaxel). Reasons given are the high cost of the new drug and concerns about adverse events. Sanofi is promoting Jevtana as a replacement for now generic Taxotere....

CHMP recommends Alimta for continuation maintenance therapy in NSCLC

The European Committee for Medicinal Products for Human Use (CHMP) delivered a positive opinion for the use of Alimta (pemetrexed) from Eli Lilly as continuation maintenance therapy in patients with advanced NSCLC who have already received an initial treatment with the agent. This opinion will now be reviewed by the European Commission. The opinion was based on the results from ...

EMA concludes Revlimid provides positive treatment for Multiple Myeloma

The EMA has confirmed that the benefit-risk balance for Revlimid (lenalidomide), from Celgene, used in combination with dexamethasone to treat adults with Multiple Myeloma remains positive. However it also advises of the risk of new cancers as a result of treatment. This review follows the results of three new studies which show a four-fold increase in new cancers (including solid ...

BOLERO-2 study of Afinitor in ER+HER-2 advanced Breast Cancer is presented at EMCC congress

A pivotal Phase III study-BOLERO-2 examined the safety and efficacy of Afinitor (everolimus) from Novartis in combination with exemestane versus exemestane alone in postmenopausal women with ER+HER2- advanced breast cancer who recurred or progressed while on or following previous treatment with hormonal therapies, letrozole or anastrozole. BOLERO-2 results show Afinitor plus exemestane, a hormonal therapy, more than doubled the time ...

BOLERO-2 study of Afinitor in ER+HER-2 advanced Breast Cancer is presented at EMCC Congress

A pivotal Phase III study-BOLERO-2 examined the safety and efficacy of Afinitor (everolimus) from Novartis in combination with exemestane versus exemestane alone in postmenopausal women with ER+HER2- advanced breast cancer who recurred or progressed while on or following previous treatment with hormonal therapies, letrozole or anastrozole. BOLERO-2 results show Afinitor plus exemestane, a hormonal therapy, more than doubled the time ...

Zometa reduces risk of Breast Cancer recurrence in post-menopausal patients

A Phase III trial investigating the use of Zometa (zoledronic acid), from Novartis, to aid chemotherapy for Breast Cancer has found a significant benefit for post-menopausal women. The AZURE trial recruited 3,360 patients with stage II/III breast cancer and an interim analysis indicated that patients were seeing no clinical benefit from treatment with Zometa so the data were released for ...

Xgeva success in Prevention of Bone Metastases in Prostate Cancer

In a phase III study of Zgeva(denosumab), men with castration-resistant prostate cancer and no previous exposure to intravenous bisphosphonate drugs (such as zoledronic acid) were enrolled from 342 centres in 39 countries. Patients were assigned 120 mg subcutaneous denosumab plus intravenous placebo, or 4 mg intravenous zoledronic acid plus subcutaneous placebo, every 4 weeks . Median time to first on-study ...

Xgeva success in Trial "147" for prevention of bone metastases in Prostate Cancer

Amgen reports results of its study "147", which not only confirmed that its 120mg dosage form of denosumab, known as Xgeva, improved median bone metastasis-free survival by 4.2 months in men with castrate-resistant prostate cancer (CRPC) versus placebo – the first time a bone-targeted drug has delayed the spread of prostate cancer to the bones – but new data showed ...

Alimta maintenance therapy positive in elderly NSCLC patients

A new subgroup analysis of data from the Phase III PARAMOUNT study showed that continuation maintenance therapy with Alimta from Eli Lilly (pemetrexed for injection) also reduces the risk of disease progression in patients aged 70 years or older with advanced nonsquamous non-small cell lung cancer (NSCLC), the most common type of lung cancer. Results from the new analysis were ...

Decalth PHP brings benefits to patients with Liver Cancer

Results from a Phase III study of Decalth PHP System (melphalan), from Decalth Systems, have demonstrated that the treatment significantly extends the time patients with melanoma of the eye (ocular or uveal melanoma), which has spread to the liver, can live without the disease progressing. Data presented at the 2011 European Multidisciplinary Cancer Congress showed that the length of time ...

Afinitor success in phase III study with angiomyolipomas, associated with Tuberous Sclerosis Complex

A Phase III study of Afinitor (everolimus)tablets from Novartus in patients with non-cancerous kidney tumors, or angiomyolipomas, associated with tuberous sclerosis complex met its primary endpoint of best overall angiomyolipoma response rate, which includes reduction in kidney tumor size and absence of new tumors. Findings from the trial, known as EXIST-2, were presented today at the International TSC Research Conference ...

Genentech files vismodegib at FDA for Basal Cell Carcinoma

Genentech/Roche has submitted a new drug application to the FDA for vismodegib as a treatment for patients with advanced, inoperable basal cell carcinoma . The new oral drug is designed to selectively inhibit signaling in the Hedgehog pathway, which is implicated in more than 90% of basal cell carcinoma cases, the most common type of skin cancer, which is generally ...

Provenge sales for Prostate Cancer disappoint Dendreon and lead to staff reduction

Dendreon will reduce its workforce by 500 employees( about one-quarter of its work force)as sales of its prostate cancer immunotherapy, Provenge(sipuleucel-T) have disappointed and are well short of its projections. The largest proposed job cuts are in manufacturing but the company is looking for a partner in Europe as its moves toward filing for approval of Provenge there by the ...

New study of Cervarix shows two doses are adequate against HPV types 16 and 18

A new study of Cervarix (papillomarvirus vaccine) from Glaxo Smith Kline, finds that to protect women from HPV types 16 and 18, which account for 70% of cervical cancer cases, two doses of the vaccine are as effective as the standard three doses over a four-year period. The study, reported in The Journal of the National Cancer Institute, uses data ...

Tarceva approved in EU as first line treatment against NSCLC with EGFR-mutations

Tarceva (erlotinib), an oral lung cancer treatment from Roche, has been officially licensed in the EU as first-line monotherapy for the treatment of patients with advanced forms of non-small cell lung cancer with EGFR-activating mutations....

Afinitor success in BOLERO 2 study in advanced Breast Cancer

An interim analysis of a pivotal Phase III study BOLERO 2, showed Afinitor (everolimus) tablets from Novartis used in combination with exemestane significantly extended progression-free survival (PFS), or time without tumor growth, when compared to placebo plus exemestane in women with advanced breast cancer. The trial was stopped early after interim results showed the primary endpoint of PFS was met. ...

First patients receive IMA 901 in Phase III Trial for Renal Cell Carcinoma

Immatics Biotechnologies announced that the first patients have been vaccinated in the IMPRINT study, a Phase III trial with IMA 901, the company's lead cancer vaccine for the treatment of Renal Cell Carcinoma (RCC). The trial is designed to demonstrate the overall survival benefit of IMA 901 in combination with standard first-line therapy in RCC patients. IMPRINT is a global ...

Selumetinib success in Phase II Biliary Cancer trial

Selumetinib, from AstraZeneca, has shown promising results in people with advanced Biliary Cancer, according to a multi-institutional clinical trial led by cancer researchers at The Ohio State University.

Selumetinib, also known as AZD 6244 (ARRY-142886), blocks a protein called MEK, which cancer cells need to proliferate and survive.- see Multi-Institutional Phase II Study of Selumetinib in Patients With Metastatic ...

FDA approves Roche Cobas HPV Test

The FDA has approved the cobas HPV (Human Papillomavirus) Test which identifies women at highest risk for developing cervical cancer. This test should help physicians make early, more accurate decisions about patient care, which may prevent many women from developing this deadly disease. The cobas HPV Test is the only FDA-approved cervical cancer screening test that allows HPV 16 and ...

NovoTTF-100A system is FDA approved for Glioblastoma

FDA recently approved the NovoTTF-100A System, a new device from Novocure Inc. to treat adults with glioblastoma multiforme (GBM) that recurs or progresses after receiving chemotherapy and radiation therapy....

Novartis discontinues Tasigna trial in GIST

Novartis is discontinuing a Phase III trial of Tasigna (nilotinib) for investigational use in the first-line treatment of gastrointestinal stromal tumors (GIST) based on the recommendation of an independent data monitoring committee. Interim results showed Tasigna is unlikely to demonstrate superiority compared to Glivec (imatinib), the current standard of care in this setting. The trial was a randomized, open-label, multicenter ...

FDA advisory committee recommends Novo TTF-100A for Glioblastoma

The FDA Neurological Devices Advisory Panel of the Medical Devices Advisory Committee voted (7 yes; 3 no; 2 abstain) that for patients with supra-tentorial glioblastoma multiforme (GBM) tumors that recur after maximal surgical and radiation treatments, there is reasonable assurance that the benefits of the NovoTTF-100A System (NovoTTF) from Novocure, outweigh its risks when administered as a monotherapy in place ...

Elacyt (Clavis Pharma) gets FDA fast track status for AML

Clavis Pharma announced that the FDA had granted fast track status to Elacyt(elacytarabine) for acute myeloid leukemia (AML). Elacytarabine is currently being evaluated in a randomised Phase III trial (known as the CLAVELA study) comparing it with the investigator's choice of treatment in patients with late-stage AML (i.e. those who have failed two or three previous treatment regimes). The primary ...