Posted by Michael Wonder on 27 Dec 2017
Agios submits new drug application to the FDA for ivosidenib for the treatment of patients with relapsed/refractory acute myeloid leukaemia and an IDH1 mutation
26 December 2017 - Ivosidenib has potential to be a first-in-class therapy for patients with relapsed/refractory AML and an IDH1 mutation.
Agios Pharmaceuticals today announced that it has submitted a new drug application to the U.S. FDA for ivosidenib (AG-120), an investigational oral treatment for patients with relapsed or refractory acute myeloid leukaemia (R/R AML) and an isocitrate dehydrogenase-1 (IDH1) mutation. Agios has requested priority review for the application, which, if granted, could result in a six-month review process.
The application is supported by data from the ongoing Phase 1 dose-escalation and expansion study of ivosidenib in patients with advanced haematologic 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.
