FDA clears Kura’s ziftomenib — first menin inhibitor approved for NPM1‑mutant AML

The U.S. FDA approved Kura Oncology and Kyowa Kirin’s ziftomenib (Komzifti) for relapsed or refractory acute myeloid leukemia with NPM1 mutations, granting the drug full approval based largely on a single‑arm Phase II study that showed durable remissions and measurable‑residual‑disease (MRD) negativity in responders. The approval arrives shortly after a competing menin inhibitor cleared a similar patient population, setting up immediate commercial and clinical competition in a genetically defined AML subset.