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# Syndax Gets Priority Review for Revuforj sNDA
- URL: https://www.fdaweb.com/syndax-gets-priority-review-for-revuforj-snda/
- Published: 2025-06-25T12:00:00.000Z
- Updated: 2026-09-14T15:15:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159412

FDA has granted Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed or refractory (R/R) acute myeloid leukemia (AML) with mutant NPM1 (mNPM1) — the most common genetic alteration found in adult AML patients. The agency has set a 10/25 user fee review action target date.

Revuforj is a first-in-class, oral menin inhibitor that received initial FDA approval in 2024 for patients with R/R acute leukemia harboring KMT2A rearrangements. The sNDA is based on data from the pivotal AUGMENT-101 trial, which evaluated revumenib in mNPM1 AML patients. The trial met its primary endpoint, demonstrating a 23% complete remission rate, with a 63% overall response rate, Syndax says. Notably, many patients achieving remission also showed minimal residual disease negativity, it says.