What is the role of enasidenib in the treatment of relapsed acute myeloid leukemia (AML)?

Updated: May 26, 2020
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

In August 2017, enasidenib—an oral, selective inhibitor of mutant-IDH2 enzymes—was approved by the FDA for treatment of relapsed/refractory IDH2-mutated AML. The approval was based on data from a phase I/II dose-escalation and expansion study (AG221-C-001) in which enasidenib proved safe and well tolerated, and induced hematologic responses. Median overall survival (OS) with enasidenib was 9.3 months. In those achieving a CR, the median OS was 19.7 months and in the non-CR responders the median OS was 13.8 months. In those without a response, the median OS was 7 months. [101]


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