The U.S. Food and Drug Administration approved ziftomenib (Komzifti), a selective oral menin inhibitor developed by Kura Oncology and Kyowa Kirin, for relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutation. The approval was based on the single‑arm phase II Komet‑001 trial, which met its primary endpoint of complete remission (CR/CRh) and demonstrated measurable residual disease (MRD) negativity in a substantial share of responders. Regulators granted breakthrough designation previously, and the agency issued approval ahead of the scheduled PDUFA date. Efficacy data showed a 22% CR/CRh rate and 33% overall response rate, with durable responses and notable MRD clearance among responders. The safety profile included expected hematologic toxicities and differentiation syndrome that was manageable under study protocols. Komzifti becomes the first approved menin inhibitor in this molecular subset, setting up near‑term competition with other targeted agents in genetically defined AML cohorts and offering a new option for patients with historically poor outcomes.