Posted by Michael Wonder on 02 Mar 2017
FDA accepts new drug application and grants priority review for enasidenib in relapsed or refractory AML with an IDH2 mutation
1 March 2017 - PDUFA date set for 30 August 2017.
Celgene Corporation and Agios Pharmaceuticals today announced that the U.S. FDA has accepted Celgene's new drug application for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed or refractory acute myeloid leukaemia with an isocitrate dehydrogenase 2 (IDH2) mutation.
The NDA was granted priority review and has been given a Prescription Drug User Fee Act action date of 30 August 2017. Celgene completed the NDA submission in late December 2016.
