Drug updated on 3/28/2024
| Dosage Form | Tablet (oral: 50 mg, 100 mg) |
| Drug Class | Isocitrate dehydrogenase-2 inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Summary
- Enasidenib (Idhifa) is used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) that have an isocitrate dehydrogenase-2 (IDH2) mutation.
- Two systematic reviews/meta-analyses were reviewed, providing insights into the efficacy and safety of enasidenib in treating IDH-mutated AML.
- The first review included a meta-analysis of 1109 IDH-mutated AML patients from 10 articles, showing promising results for relapsed or refractory AML patients with IDH mutations but less optimal outcomes for newly diagnosed cases due to low complete remission rates.
- In this study, gastrointestinal adverse events were most common among all-grade adverse events while hematologic ones were frequently occurring at grade 3 or higher; physicians are advised to manage differentiation syndrome caused by these inhibitors carefully.
- The second review screened over three thousand articles and included nine clinical trials involving 1119 participants; it reported objective response rates between 63% -74% when combining IDH inhibitors with azacitidine compared to only19%-36% when using azacitidine monotherapy in medically unfit newly diagnosed patients.
- This document also highlighted potential side effects such as ≥Grade 3 IDH differentiation syndrome and QT prolongation observed in some patient groups; however, it concluded that enasidenib was safe and effective overall despite no survival benefit being reported specifically for this drug yet more research is needed to confirm these findings against other targeting agents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Idhifa (enasidenib) Prescribing Information. | 2020 | Celgene Corporation, Summit, NJ |