New FDA green light for Syndax’ Revuforj

The US Food and Drug Administration (FDA) has approved Revuforj (revumenib) for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options.

Developed by USA-based Syndax Pharmaceuticals (Nasdaq: SNDX), Revuforj previously received FDA approval in 2024 for the treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older. Revuforj is the first and only FDA-approved therapy for both R/R AML with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation.