FDA grants Priority Review to Teva's Trisenox sNDA

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said FDA accepted and granted Priority Review to an sNDA for Trisenox arsenic trioxide plus all-trans retinoic acid (ATRA) for induction of remission and consolidation in patients with newly diagnosed low or intermediate risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or promyelocytic leukemia-retinoic acid receptor alpha (PML-RARA) gene expression. Teva said its PDUFA date is 1Q18.

Trisenox is approved for induction of remission and consolidation of APL refractory to or relapsed from retinoid and anthracycline chemotherapy, and characterized by the presence of the t(15;17) translocation or PML-RARA gene expression...