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Enasidenib

(Idhifa®)

Idhifa®

Drug updated on 12/11/2024

Dosage FormTablets (oral; 50 mg, 100 mg)
Drug ClassIsocitrate dehydrogenase-2 inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • In newly diagnosed IDH-mutated Acute Myeloid Leukemia (AML) patients, the complete remission (CR) rate was 47%, and the overall response rate (ORR) was 65%. The 2-year overall survival (OS) rate was 45%, and the 2-year event-free survival (EFS) rate was 29%.
  • In relapsed or refractory (R/R) isocitrate dehydrogenase (IDH)-mutated AML patients, the CR rate was lower at 21%, with an ORR of 40%. The 2-year OS rate was 15%, and the median OS was 8.21 months, while the median EFS was 4.73 months.
  • Newly diagnosed patients had higher response rates and survival outcomes compared to R/R patients, with significant differences in CR, ORR, and 2-year OS rates.
  • The most frequently reported adverse events were gastrointestinal in nature for all grades and hematologic events for ≥ grade 3 severity. Differentiation syndrome was highlighted as a specific concern that requires careful management.
  • No comparative safety data for other drugs were provided in the study.
  • The population types included 715 newly diagnosed patients with IDH-mutated AML and 394 patients with relapsed or refractory (R/R) IDH-mutated AML.