FDA Grants Priority Review to Enasidenib for IDH2-Mutant AML

March 1, 2017 – The FDA has granted a priority review to a new drug application (NDA) for enasidenib (AG-221) as a treatment for patients with relapsed or refractory IDH2-mutated acute myeloid leukemia (AML), according to a statement from Celgene and Agios, the codevelopers of the targeted therapy. The priority review is based on data from the phase I/II AG221-C-001 study, which was presented at the 2015 ASH Annual Meeting. In the single-arm trial, the objective … (leggi tutto)