The U.S. Food and Drug Administration approved ziftomenib (Komzifti) from Kura Oncology and Kyowa Kirin for relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutation. The decision was granted ahead of the original PDUFA date and is based on single-arm Phase II Komet‑001 data showing durable remissions and measurable residual disease (MRD) negativity in a subset of responders. The approval cites a 22% complete remission (CR/CRh) rate and an overall response rate near 33% in heavily pretreated patients, with manageable safety and a notable rate of MRD negativity among responders. Kura and Kyowa provided the pivotal data; regulators accepted a single-arm study given the high unmet need in this genetically defined, late‑line population. Clinicians and investors will watch post‑approval commercialization and real‑world tolerability, especially differentiation‑syndrome management and hematologic safety, as Kura and Kyowa roll Komzifti into practice.