FDA Grants Priority Review To Syndax's Revuforj For R/R MNPM1 Acute Myeloid Leukemia Treatment

(RTTNews) - Syndax Pharmaceuticals (SNDX) announced that the U.S. Food and Drug Administration has granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj (revumenib) for the treatment of relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML).

The sNDA is being reviewed under the FDA's Real-Time Oncology Review (RTOR) program and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025.

Real-Time Oncology Review allows for a more efficient review and close engagement between the sponsor and the FDA throughout the submission process.

Revuforj is an oral, first-in-class menin inhibitor that was FDA approved in 2024 for the treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older.

The sNDA, if approved, would expand the indication for Revuforj to include patients with R/R AML who have an NPM1 mutation, the most common genetic alteration in AML.

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