Drug updated on 9/4/2024
Dosage Form | Tablet (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.
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Summary
- Idhifa (enasidenib) is 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.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Newly Diagnosed IDH-Mutated AML: In a meta-analysis, the CR rate was 47%, ORR was 65%, with a 2-year OS rate of 45% and a 2-year EFS rate of 29%. Combination therapy with azacitidine resulted in ORR of 63-74% in RCTs, compared to 19-36% with azacitidine monotherapy.
- Relapsed/Refractory IDH-Mutated AML: The meta-analysis reported a CR rate of 21% and an ORR of 40%, with a 2-year OS rate of 15%, a median OS of 8.21 months, and a median EFS of 4.73 months. In RCTs, the ORR ranged from 39.1% to 46%.
- Comparison of IDH Inhibitors: IDH inhibitors combined with azacitidine in newly diagnosed patients showed significantly higher ORR (63-74%) compared to azacitidine monotherapy (19-36%). Ivosidenib was associated with improved survival rates, unlike enasidenib, which did not show a survival benefit.
- The most frequently occurring all-grade adverse events associated with IDH inhibitors are gastrointestinal, while ≥Grade 3 adverse events are predominantly hematologic in nature.
- IDH Differentiation Syndrome is a notable adverse event with a reported incidence of 3.9-10% in RCTs. QT prolongation is another observed adverse event, reported in 2-10% of patients in RCTs.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Idhifa (enasidenib) Prescribing Information. | 2023 | Celgene Corporation., Summit, NJ |