The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide.
Teva Pharmaceutical has obtained approval from the European Commission for an indication extension of Trisenox (arsenic trioxide) in treatment for...
Pfizer Inc. announced that the European Commission has approved Mylotarg (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine for the...
Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has...
The development of FLT3-targeted inhibitors represents an important paradigm shift in the management of patients with highly aggressive fms-like tyrosine kinase 3-mutated (FLT3-mut) acute myeloid leukemia (AML).
The phase III ENHANCE-2 trial (NCT04778397) examining the frontline combination of magrolimab and azacitidine (Vidaza) vs physician’s choice of venetoclax (Venclexta) with azacitidine or intensive chemotherapy in patients with acute myeloid leukemia and TP53 mutations has been discontinued, according to an announcement from Gilead Sciences
Allogeneic hematopoietic stem cell transplantation (HSCT) is an integral therapy for patients with hematological malignancies, myelodysplasia, and bone marrow failure. Its use has been increasing over the past decade...
Arsenic Trioxide STADA is indicated for induction of remission, and consolidation in adult patients with: • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 10 3 /μl) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
Areas covered: To the best of our knowledge, the role and efficacy of 7 + 3 schedules containing daunorubicin (DNR) and Ara-C for certain types of poor-prognosis AML has not been systematically assessed.
Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 10 3 /µl) in combination with all-trans-retinoic acid (ATRA) • Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.