Syndax Announces FDA Priority Review Of NDA For Revumenib For Treatment Of R/R KMT2Ar Acute Leukemia

(RTTNews) - Syndax Pharmaceuticals (SNDX) said that the U.S. Food and Drug Administration has granted Priority Review for its New Drug Application or NDA for revumenib, the company's first-in-class menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged or KMT2Ar acute leukemia.

The NDA filing is being reviewed under the FDA's Real-Time Oncology Review Program (RTOR) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2024. RTOR allows for a more efficient review and close engagement between the sponsor and the FDA throughout the submission process, which historically has led to earlier approvals.

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