The FDA approved ziftomenib (Komzifti), an oral selective menin inhibitor, for relapsed/refractory NPM1‑mutant acute myeloid leukemia (AML), delivering clearance more than two weeks ahead of the scheduled PDUFA date. The approval provides a targeted option for NPM1‑mutant disease, a defined molecular subset with high unmet need. The accelerated timeline underscores the regulator’s willingness to expedite therapies for molecularly defined hematologic malignancies. The approval sets up rapid clinical adoption and will prompt payers and centers to update molecular testing algorithms to identify eligible patients. For the menin inhibitor class, the Komzifti approval validates targeting epigenetic dependencies in AML and may catalyze combination studies and earlier‑line development across NPM1‑mutant populations.