The U.S. FDA approved ziftomenib (Komzifti), the selective oral menin inhibitor developed by Kura Oncology and Kyowa Kirin, for relapsed or refractory NPM1‑mutant acute myeloid leukemia, granting clearance more than two weeks ahead of its scheduled PDUFA date. The approval recognizes a targeted oral menin inhibition strategy in a genetically defined AML subgroup. Ziftomenib’s label and expedited review underscore the regulatory receptivity to mechanism‑driven therapies for molecularly stratified hematologic malignancies. The approval provides an immediately available oral option for a high‑unmet‑need population and may accelerate menin‑directed programs across the sector. Sources: FDA notice and company communications.