Drug updated on 10/30/2024
| Dosage Form | Tablets (oral; 50 mg, 100 mg) |
| Drug Class | Isocitrate 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.
Latest News
Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [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) 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.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Idhifa (enasidenib) Prescribing Information. | 2023 | Bristol-Myers Squibb, Princeton, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of FDA-approved IDH inhibitors in the treatment of IDH mutated acute myeloid leukemia: a systematic review and meta-analysis | 2023 | Clinical Epigenetics |