Agios Pharmaceuticals submits new FDA application for Ivosidenib
Agios Pharmaceuticals announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for ivosidenib, an investigational oral treatment for patients with relapsed or refractory acute myeloid leukemia and an isocitrate dehydrogenase-1 mutation. Agios has requested priority review for the application, which, if granted, could result in a six-month review process. The NDA 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. Ivosidenib is wholly owned by Agios. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.