Syndax Pharmaceuticals' Revumenib Gets Category 2A NCCN Recommendation for AML.

Syndax Pharmaceuticals announced that the National Comprehensive Cancer Network (NCCN) Guidelines for Acute Myeloid Leukemia have been updated to include revumenib as a category 2A recommendation for relapsed or refractory AML with an NPM1 mutation. This recommendation is based on positive results from the AUGMENT-101 trial published in the journal Blood in 2025. Revumenib is also recommended for R/R acute leukemia with a KMT2A rearrangement.

Syndax Pharmaceuticals (NASDAQ: SNDX) has announced a significant milestone in its drug development pipeline, with the National Comprehensive Cancer Network (NCCN) Guidelines for Acute Myeloid Leukemia (AML) updated to include its drug revumenib as a category 2A recommendation for relapsed or refractory (R/R) AML with an NPM1 mutation. This update is based on positive results from the AUGMENT-101 trial, published in the journal Blood in 2025 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^[1].

The NCCN Guidelines, considered the gold standard for clinical decision-making in oncology, now recommend revumenib for R/R mNPM1 AML. This recommendation expands the drug's addressable patient population beyond its existing recommendation for KMT2A-rearranged leukemias. The timing of this update is strategic, coinciding with the FDA's Priority Review decision expected by October 25, 2025 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^[1].

Revumenib, an oral menin inhibitor, has been granted Priority Review by the FDA for its supplemental New Drug Application (sNDA) seeking approval for the treatment of R/R mNPM1 AML. The drug is supported by compelling data from the AUGMENT-101 trial, which demonstrated its efficacy in a difficult-to-treat population where therapeutic options remain limited 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^[1].

The inclusion of revumenib in the NCCN Guidelines is expected to facilitate reimbursement pathways, as both private and public payers heavily reference these recommendations when establishing coverage policies. This development positions Syndax advantageously in the competitive landscape for targeted AML therapies, potentially accelerating clinical adoption once the expected label expansion receives FDA approval 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^[1].

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 numerous stakeholders in the healthcare delivery system 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^[1].