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# Syndax Leukemia Review Extended by FDA
- URL: https://www.fdaweb.com/syndax-leukemia-review-extended-by-fda/
- Published: 2024-07-29T12:00:00.000Z
- Updated: 2026-09-14T14:36:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157447

FDA has extended by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric patients with relapsed or refractory (R/R) KMT2Ar acute leukemia. The agency says the extension is necessary to review supplemental information provided in response to its requests. If approved, revumenib would be the first drug indicated to treat patients with KMT2A-rearranged acute leukemia, a population with significant unmet need, according to the company. The revised user fee review action date is 9/26.

Revumenib is described as a potent, selective, small molecule inhibitor of the menin-KMT2A binding interaction. “Positive topline results from the Phase 2 AUGMENT-101 trial in R/R KMT2Ar acute leukemia showing the trial met its primary endpoint were presented at the 65th American Society of Hematology Annual Meeting, and data from the Phase 1 portion of AUGMENT-101 in acute leukemia was published in *Nature*,” Syndax says.

The submission is being reviewed under FDA’s Real-Time Oncology Review Program, which provides a “close engagement between the sponsor and the FDA throughout the submission process and it enables the FDA to review individual sections of modules of a drug application rather than requiring the submission of complete modules or a complete application prior to initiating review,” the company says.