Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 04 September 2018
Temodal is indicated for the treatment of:
- adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
- children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
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Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas (INTELLANCE 2)
This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide versus temozolomide or lomustine alone in participants with recurrent glioblastoma multiforme.
Added 2 years ago
Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In brain tumor resection craniotomy, it is proven to be effective in improving postoperative hypertension and...
Added 2 years ago
The trial includes i) the evaluation of the efficacy of a treatment strategy, designed as a phase II trial, and...
Added 6 years ago
Phase I / II study of sequential high-dose chemotherapy with stem cell support in children younger than 5 years of age with high-risk medulloblastoma
Phase II: To assess the efficacy in terms of Event Free Survival (EFS) of the strategy intended to treat children...
Added 7 years ago
A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies. (SHINE)
The primary objective is to evaluate the long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in...
Added 1 day ago
First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma.
This Phase 3 trial evaluates the addition of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax®-L) to standard therapy for newly diagnosed glioblastoma.
Added 1 year ago
Preclinical drug screen reveals topotecan, actinomycin D, and volasertib as potential new therapeutic candidates for ETMR brain tumor patients.
Background: Embryonal tumor with multilayered rosettes (ETMR) is a rare and aggressive embryonal brain tumor that solely occurs in infants and young children and has only recently been recognized as a separate brain tumor entity...
Added 1 year ago
Oncolytic viral (OV) therapy, which uses genetically engineered tumor-targeting viruses, is being increasingly used in cancer clinical trials due to...
Added 3 years ago
Temozolomide (TMZ) is an oral alkylating chemotherapeutic agent that prolongs the survival of patients with glioblastoma (GBM). Despite that high...
Added 4 years ago
This guideline covers diagnosing, monitoring and managing any type of primary brain tumour or brain metastases in people aged 16 or over. It aims to improve diagnosis and care, including standardising the care people have...
Added 1 month ago
This update covers recommendations for glioblastoma; anaplastic astrocytoma, oligoastrocytoma and oligodendroglioma; and diffuse glioma. The recommendations cover clinically relevant problems in: diagnosis and pathology...
Added 5 years ago
End of life care for infants, children and young people with life-limiting conditions: planning and management
This guideline covers the planning and management of end of life and palliative care in for infants, children and young people (aged 0–17 years) with life-limiting conditions. It aims to involve children, young people and their families...
Added 20 days ago
This guideline covers the initial assessment of symptoms and signs that might indicate a neurological condition. It helps non-specialist healthcare professionals to identify people who should be offered referral for specialist investigation.
Added 1 month ago
|Agency product number||EMEA/H/C/000229|
|Date First Approved||26-01-1999|
|Type||Medicinal product subject to restricted medical prescription|
|Marketing authorisation holder||Merck Sharp & Dohme B.V.|