The FDA approved ziftomenib (Komzifti), Kura Oncology and Kyowa Kirin’s oral menin inhibitor, for relapsed or refractory acute myeloid leukemia (AML) harboring NPM1 mutations. The decision was supported by the single‑arm phase II KOMET‑001 trial, which reported a 33% overall response rate (CR/CRh) and deep responses with 61% of evaluable responders achieving MRD negativity. Kura CEO Troy Wilson highlighted the regulatory willingness to approve on single‑arm data in this late‑line setting; differentiation syndrome occurred but was manageable under study protocols. The approval establishes the first FDA‑cleared therapy targeted to NPM1‑mutant AML and sets an efficacy benchmark for menin inhibitors in this genetically defined population. Menin inhibitors modulate transcriptional programs driven by menin‑MLL interactions — a targeted epigenetic mechanism increasingly exploited in hematologic oncology. Clinicians and trialists will watch post‑approval safety monitoring and efforts to move menin inhibition earlier in AML treatment paradigms.