Posted by Michael Wonder on 24 Oct 2025
FDA approves revumenib for relapsed or refractory acute myeloid leukaemia with a susceptible NPM1 mutation
24 October 2025 - Today, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals), a menin inhibitor, for relapsed or refractory acute myeloid leukaemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and paediatric patients 1 year and older who have no satisfactory alternative treatment options.
Efficacy was evaluated in a single-arm cohort of an open-label, multi-centre trial (SNDX-5613-0700, AUGMENT-101).
