Syndax’s Revuforj® (revumenib) Included in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the Treatment of Relapsed or Refractory NPM1 Mutated Acute Myeloid Leukemia

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[{"type":"text","content":"NEW YORK, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia were updated to include revumenib as a category 2A recommendation for relapsed or refractory (R/R) acute myeloid leukemia (AML) with an NPM1 mutation (mNPM1).1 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 inclusion of revumenib as a recommended treatment option for R/R NPM1 mutated AML in the NCCN Guidelines underscores the strength of our clinical data in this population and further solidifies revumenib’s leading position,” said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. “Given the pivotal role NCCN Guidelines play in guiding the decision-making process for clinicians, payers, patients, and other key stakeholders in the U.S. and beyond, this is a major milestone for Syndax and the entire acute leukemia community.” The Company has submitted a supplemental New Drug Application (sNDA) 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 (PDUFA) target action date of October 25, 2025. The NCCN is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. About Mutant NPM1 (mNPM1) Acute Myeloid Leukemia (AML) Mutations in the NPM1 gene are the most common genetic alteration observed in AML, occurring in approximately 30% of adults with AML. Mutations in this gene play a critical role in the development of mutant NPM1 (mNPM1) AML, an aggressive blood cancer associated with high rates of relapse. Patients with relapsed ...

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