Syndax Pharmaceuticals Announces FDA Approval of Revuforj for R/R Acute Leukemia with KMT2A Translocation and Submits Supplemental NDA for R/R mNPM1 AML

Reuters
12 Jun
Syndax Pharmaceuticals Announces FDA Approval of Revuforj for R/R Acute Leukemia with KMT2A Translocation and Submits Supplemental NDA for R/R mNPM1 AML

NEW YORK, June 12, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, a commercial-stage biopharmaceutical company, announced new data from the AUGMENT-101 trial of their menin inhibitor, Revuforj® (revumenib), during the 30th European Hematology Association Annual Congress. These findings have led to the FDA approval of Revuforj for patients with relapsed or refractory acute leukemia featuring a KMT2A translocation. Additionally, these results underpin a supplemental New Drug Application (NDA) submitted to the FDA for treating relapsed or refractory mutant NPM1 acute myeloid leukemia $(AML.AU)$, addressing a significant unmet medical need.

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