Posted by Michael Wonder on 13 Nov 2025
FDA approves ziftomenib for relapsed or refractory acute myeloid leukaemia with a NPM1 mutation
13 November 2025 - Today, the FDA approved ziftomenib (Komzifti, Kura Oncology), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukaemia with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.
Efficacy was evaluated in KO-MEN-001, an open-label, single, arm, multicenter trial in 112 adults with relapsed or refractory acute myeloid leukaemia with an NPM1 mutation identified using next-generation sequencing or polymerase chain reaction.
