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Syndax's Revumenib Added to National Cancer Guidelines for NPM1-Mutant Acute Myeloid Leukemia
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Syndax's Revumenib Added to National Cancer Guidelines for NPM1-Mutant Acute Myeloid Leukemia
Sep 21, 2025 12:38 AM

08:05 AM EDT, 09/19/2025 (MT Newswires) -- Syndax Pharmaceuticals ( SNDX ) said Friday the National Comprehensive Cancer Network included its blood cancer drug Revuforj, or revumenib, as a category 2A recommendation in the Clinical Practice Guidelines in Oncology for relapsed or refractory acute myeloid leukemia with an NPM1 mutation, an aggressive blood cancer associated with high rates of relapse.

The update follows positive pivotal results from the AUGMENT-101 trial of revumenib, the company said.

The guidelines continue to include revumenib as a category 2A recommendation for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene, or KMT2A rearrangement.

Syndax said its supplemental new drug application for revumenib in relapsed or refractory mutant NPM1 AML has been granted FDA Priority Review and was assigned a Prescription Drug User Fee Act target action date of Oct. 25.

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