Teva Pharmaceutical has obtained approval from the European Commission for an indication extension of Trisenox (arsenic trioxide) in treatment for...
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.
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...