Drug updated on 11/27/2024
| Dosage Form | Tablet (oral; 25 mg, 110 mg, 160 mg) |
| Drug Class | Menin inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
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Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Efficacy Outcomes: Revumenib (SNDX-5613) demonstrated a 30% complete remission / complete remission with partial haematologic recovery (CR/CRh) rate in patients with relapsed or refractory acute leukemia, including those refractory to multiple prior therapies.
- Population and Subgroups: The study focused on relapsed or refractory acute leukemia patients, with relevant findings highlighting efficacy in leukemias associated with lysine methyltransferase 2A (KMT2A) rearrangements (10% of acute leukemias) and nucleophosmin 1 (NPM1) mutations (30% of acute myeloid leukemias).
- Therapy with revumenib was associated with a low frequency of grade 3 or higher treatment-related adverse events; the only dose-limiting toxicity was asymptomatic prolongation of the QT interval on electrocardiography.
- Differentiation syndrome was reported, indicating differentiation into normal hematopoietic cells, relevant to the therapeutic outcome.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Revuforj (revumenib) Prescribing Information. | 2024 | Syndax Pharmaceuticals, Inc., Waltham, MA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| The menin inhibitor revumenib in KMT2A-rearranged or NPM1-mutant leukaemia | 68Subjects F: 62% M: 38% | 2023 | Nature |
Sex Distribution:
F:62%
M:38%
68Subjects
Year:
2023
Source:Nature