Syndax (SNDX) Pharmaceuticals announced that the National Comprehensive Cancer Network, NCCN, Clinical Practice Guidelines in Oncology for Acute Myeloid Leukemia, AML, were updated to include revumenib as a category 2A recommendation for relapsed or refractory acute myeloid leukemia with an NPM1 mutation. The update was based on positive pivotal results from the AUGMENT-101 trial of revumenib which were published in the journal Blood in 2025.2 The NCCN Guidelines for AML and acute lymphoblastic leukemia, ALL, continue to also include revumenib as a category 2A recommendation for R/R acute leukemia with a KMT2A rearrangement. The Company has submitted a supplemental New Drug Application seeking the approval of revumenib for the treatment of R/R mNPM1 AML. The sNDA has been granted Priority Review by the FDA and assigned a Prescription Drug User Fee Act target action date of October 25, 2025.
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