The U.S. Food and Drug Administration approved Kura Oncology and Kyowa Kirin’s ziftomenib (Komzifti), a selective oral menin inhibitor, for relapsed or refractory acute myeloid leukemia with NPM1 mutations. The approval arrived more than two weeks ahead of the scheduled PDUFA date and grants a new targeted option for a genetically defined AML subgroup. The decision expands the targeted‑therapy toolkit in AML where menin‑MLL pathway inhibition has been a major mechanistic focus. Ziftomenib’s oral profile positions it for outpatient dosing strategies and potential combination trials in earlier lines of therapy. Clarification: menin inhibitors disrupt a protein complex that drives transcriptional programs in MLL‑rearranged and NPM1‑mutant leukemias, reprogramming malignant cells toward differentiation and cell death.