FDA approves second targeted AML drug Idhifa
FDA approved Idhifa enasidenib (AG-221) from Celgene Corp. (NASDAQ:CELG) and partner Agios Pharmaceuticals Inc. (NASDAQ:AGIO) to treat adults with relapsed or refractory acute myelogenous leukemia with an isocitrate dehydrogenase 2 (IDH2) mutation. Idhifa is an inhibitor of mutated IDH2. FDA concurrently approved the RealTime IDH2 companion diagnostic from Abbott Laboratories (NYSE:ABT).
Idhifa is the second targeted agent approved to treat a molecularly defined subgroup of AML patients in just over three months. AML has leapfrogged the drug development paradigm in cancer where most have followed an often slow progression from chemotherapy, to agents that target features prevalent among a classically defined cancer type, to personalized approaches. Now with two targeted agents in biomarker defined subgroups, AML has jumped straight from step one to step three (see BioCentury, Dec. 9, 2016)...