The U.S. Food and Drug Administration approved ziftomenib (Komzifti) from Kura Oncology and Kyowa Kirin to treat relapsed or refractory acute myeloid leukemia with NPM1 mutations. The approval was based on single‑arm phase II data (Komet‑001) showing meaningful complete remission rates and measurable residual disease negativity among responders. Komzifti is a selective oral menin inhibitor that targets a genetically defined AML subset associated with poor outcomes. Regulators granted breakthrough designation, and approval came ahead of the original PDUFA date, reflecting the unmet need in this molecularly defined, late‑line population. The clearance adds a new targeted option to a difficult therapeutic area and demonstrates continued regulatory willingness to approve targeted oncology agents on robust single‑arm datasets when alternatives are limited. Commercially, Komzifti establishes Kura and Kyowa Kirin in a niche precision oncology segment where molecular testing is required to identify eligible patients.