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FDA Approves Enasidenib for IDH2-Mutated AML

Silas Inman @silasinman
Published: Tuesday, Aug 01, 2017

Richard Pazdur, MD

Richard Pazdur, MD
The FDA has approved enasidenib (Idhifa) as a treatment for patients with relapsed or refractory IDH2-mutated acute myeloid leukemia (AML), based on findings from a phase I/II study. A companion diagnostic, the RealTime IDH2 Assay, was also approved for the detection of the IDH2 mutation.

-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 DC, Pollyea DA, et al. Enasidenib in mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML): Results of a phase I dose-escalation and expansion study. J Clin Oncol 35, 2017 (suppl; abstr 7004).

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