All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.

  TRANSLATE

The aml Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the aml Hub cannot guarantee the accuracy of translated content. The aml and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.

Now you can support HCPs in making informed decisions for their patients

Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.

Find out more

The FDA grants enasidenib priority review for treatment of R/R AML with IDH2 mutation

By Cynthia Umukoro

Share:

Mar 3, 2017


On 1st March 2017, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted priority review to enasidenib for the treatment of Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) with an Isocitrate Dehydrogenase 2 (IDH2) mutation.1

Somatic gain of function mutations in IDH2 are observed in patients with AML. IDH2 mutations can lead to the accumulation of the oncometabolite 2-Hydroxyglutarate (2-HG). 2-HG can inhibit TET2, which can lead to epigenetic dysregulation and a block in cellular differentiation. Enasidenib (AG221) is a reversible, selective inhibitor of mutated IDH2. Enasidenib binds and inhibits the mutant IDH2 enzyme that is responsible for the accumulation of 2-HG.2

At present, enasidenib is being explored in a phase III (NCT02577406) randomized study. In this study, the safety and efficacy of enasidenib is compared to conventional care regimens in older AML patients that are R/R after second or third-line AML therapy and are positive for IDH2 mutation. The primary endpoint of the study is overall survival.

References