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# Celgene’s Idhifa Approved for Leukemia
- URL: https://www.fdaweb.com/celgenes-idhifa-approved-for-leukemia/
- Published: 2017-08-01T12:00:00.000Z
- Updated: 2026-09-14T22:37:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139275

FDA has approved Celgene’s Idhifa (enasidenib) for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, Abbott’s RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML, according to an agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569421.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery). “The use of Idhifa was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions,” FDA Oncology Center of Excellence director **Richard Pazdur** is quoted in the release as saying.  
  
Idhifa is described by FDA as an isocitrate dehydrogenase-2 inhibitor that works by blocking several enzymes that promote cell growth. “The efficacy of Idhifa was studied in a single-arm trial of 199 patients with relapsed or refractory AML who had IDH2 mutations as detected by the RealTime IDH2 Assay,” it says. After six months of treatment, 19% of patients experienced complete remission for a median 8.2 months, and of the 157 patients who required transfusions of blood or platelets due to AML at the start of the study, 34% no longer required transfusions after treatment with Idhifa.