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FDA Grants Priority Review to Enasidenib for IDH2-Mutant AML

Silas Inman @silasinman
Published: Wednesday, Mar 01, 2017

Dr David Schenkein

David Schenkein, MD

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.

-mutant AML. The trial, which is still enrolling, plans to include 280 participants with an estimated primarily completion date in April 2019. In this study, conventional therapy will consist of azacitidine and low- or intermediate-dose cytarabine. All patients will receive best supportive care (NCT02577406).
Stein EM, DiNardo C, Altman JK, et al. Safety and Efficacy of AG-221, a Potent Inhibitor of Mutant IDH2 That Promotes Differentiation of Myeloid Cells in Patients with Advanced Hematologic Malignancies: Results of a Phase 1/2 Trial. Blood. 2015;126:323.

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