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...
TRISENOX 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.
The EU's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms...