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.

The therapy's NDA is based on data from a Phase I trial in patients with advanced hematologic malignancies and an IDH1 mutation.

Abbott Laboratories (NYSE:ABT) has submitted an application to FDA seeking premarket approval of a companion diagnostic for ivosidenib that detects the IDH1 mutation in bone marrow and blood. The companies partnered in 2014 to develop an IDH1 assay.

Agios markets Idhifa enasidenib, an inhibitor of IDH2, and is strengthening its commercial business in preparation for ivosidenib's potential launch (see BioCentury, Sept. 29, 2017).

Agios climbed $0.82 to $78.79 on Thursday.