The U.S. Food and Drug Administration approved ziftomenib (Komzifti) from Kura Oncology and Kyowa Kirin to treat relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutations. The approval, supported by single‑arm phase II Komet‑001 data, grants a new targeted option for a genetically defined subset of AML patients who historically have poor outcomes. Komzifti demonstrated durable responses in the trial, including measurable residual disease negativity in a majority of evaluable responders; differentiation syndrome was observed and managed per protocol. The approval arrived ahead of the product’s PDUFA date and follows breakthrough designation by the FDA. Regulators and clinicians will monitor real‑world safety, the management of differentiation syndrome, and sequencing with other AML therapies. The decision may prompt additional development and combination studies and reshapes competitive dynamics for menin inhibitors in hematologic oncology.