The U.S. FDA approved ziftomenib (Komzifti), a selective oral menin inhibitor developed by Kura Oncology and Kyowa Kirin, for relapsed or refractory NPM1‑mutant acute myeloid leukemia (AML) ahead of its PDUFA date. The clearance recognizes a targeted small‑molecule approach against a genetically defined AML subset and establishes menin inhibition as a clinically actionable mechanism in this population. Approval opens a new targeted therapy option for a high‑risk AML cohort and will prompt integration of NPM1 mutational testing into diagnostic workflows. Biopharma competitors with menin programs and payers will assess long‑term benefit, real‑world uptake, and biomarker‑driven patient selection strategies. Clinical teams and diagnostics labs will need to coordinate rapid genotyping to identify eligible patients for Komzifti therapy.