The FDA approved ziftomenib (Komzifti), a selective oral menin inhibitor from Kura Oncology and Kyowa Kirin, to treat relapsed or refractory NPM1‑mutant acute myeloid leukemia. Approval was based on single‑arm phase II Komet‑001 data showing meaningful complete remission and measurable residual disease (MRD) negativity in a difficult‑to‑treat population. Regulators granted breakthrough designation and accepted the phase II dataset for full approval, citing durable responses and a tolerable safety profile. The label positions Komzifti as a first‑in‑class option for NPM1‑mutant AML and sets a precedent for approvals in genomically defined hematologic subtypes based on single‑arm evidence.