Posted by Michael Wonder on 15 Feb 2018
FDA accepts new drug application and grants priority review for ivosidenib in relapsed or refractory AML with an IDH1 mutation
15 February 2018 - PDUFA date set for 21 August 2018
Agios Pharmaceuticals today announced that the U.S. FDA has accepted the company’s new drug application for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukaemia with an isocitrate dehydrogenase 1 (IDH1) mutation.
The application was granted priority review and has been given a Prescription Drug User Fee Act action date of 21 August 2018. Agios completed the submission in late December 2017.
