Celgene: FDA Grants Priority Review For Enasidenib - Quick Facts

(RTTNews) - Celgene Corp. (CELG) and Agios Pharmaceuticals (AGIO) announced the U.S. FDA has accepted Celgene's New Drug Application (NDA) for enasidenib for the treatment of patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2, or IDH2 mutation. The NDA was granted Priority Review and has been given a PDUFA action date of Aug. 30, 2017.

Enasidenib is an oral, targeted inhibitor of mutant IDH2. The NDA submission is based on results from AG221-C-001, a single-arm phase I/II study of enasidenib in patients with advanced hematologic malignancies with an IDH2 mutation. Enasidenib is an investigational drug that has not been approved for any use in any country.