Priority Review for Agios' ivosidenib

Agios Pharmaceuticals Inc. (NASDAQ:AGIO) said FDA accepted and granted Priority Review to an NDA for ivosidenib (AG-120) to treat relapsed or refractory acute myelogenous leukemia (AML) in patients with an isocitrate dehydrogenase 1 (IDH1) mutation. The PDUFA date is Aug. 21.

Ivosidenib is a small molecule inhibitor of mutated IDH1. It is the most advanced program targeting IDH1, according to BioCentury's BCIQ database. Agios said ivosidenib could become the first targeted treatment for relapsed or refractory AML patients with an IDH1 mutation...