The FDA approved ziftomenib (Komzifti), an oral selective menin inhibitor developed by Kura Oncology and Kyowa Kirin, for treatment of relapsed or refractory (r/r) NPM1‑mutant acute myeloid leukemia (AML). Approval arrived ahead of the Nov. 30 PDUFA date, signaling regulator urgency for a genetically defined AML subgroup with limited options. Ziftomenib targets the menin–MLL interaction to suppress oncogenic transcriptional programs in NPM1‑mutant AML; menin inhibitors have emerged as a targeted approach for leukemias driven by specific chromatin and transcriptional dependencies. The clearance provides a new oral targeted therapy option for a defined molecular cohort and accelerates clinical adoption discussions. Kura and Kyowa Kirin now transition to commercial roll‑out and further development plans, including exploring combination strategies and additional genetically selected indications where menin dependence may be present.