The FDA approved Kura Oncology and Kyowa Kirin’s ziftomenib (Komzifti) to treat relapsed or refractory acute myeloid leukemia with NPM1 mutations, based on phase II Komet‑001 data showing meaningful complete remission and MRD‑negative rates in a poor‑prognosis population. The approval arrived ahead of the PDUFA date and gives clinicians a targeted oral option in an area with limited therapies. Komzifti demonstrated a 22% CR/CRh rate and durable responses among responders, with a notable proportion achieving MRD negativity. Safety signals—differentiation syndrome, cytopenias and febrile neutropenia—were manageable under study protocols. Kura’s approval creates direct commercial overlap with Syndax and other menin programs and will prompt competition over sequencing and combination strategies in AML. Regulators’ willingness to grant full approval on single‑arm data highlights continued flexibility in hematology where unmet need is high, but it also raises the bar for post‑approval evidence generation and real‑world safety monitoring.