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Agios submits leukemia drug application to US FDA

Agios Pharmaceuticals Inc. filed an application seeking approval for ivosidenib from the U.S. Food and Drug Administration.

The investigational oral treatment, also known as AG-120, is meant for patients whose acute myeloid leukemia patients whose disease has either returned or is resistant to treatment and exhibits the isocitrate dehydrogenase-1, or IDH1, mutation.

The Cambridge, Mass.-based company is seeking a priority review of the application which is supported by data from the ongoing phase 1 dose-escalation and expansion study of ivosidenib in patients with advanced hematologic malignancies and an IDH1 mutation.