The FDA granted approval to ziftomenib (Komzifti) for relapsed or refractory acute myeloid leukemia with NPM1 mutations, marking Kura Oncology’s first approved therapy. The decision relied on the single‑arm Phase II Komet‑001 trial that showed complete remissions and durable responses in a hard‑to‑treat population. Troy Wilson, Kura’s CEO, framed the approval as validation of the menin‑inhibitor approach. Regulators accepted response and durability data, including measurable residual disease (MRD) conversions in responders. Safety signals were consistent with expectations for late‑line AML; differentiation syndrome was observed and managed per protocols. The approval narrows an aggressive unmet need and immediately changes the competitive landscape where a Syndax drug already targets similar patients. Clinicians and payers will now focus on real‑world tolerability, sequencing with existing agents (venetoclax, FLT3/IDH inhibitors), and access. Expect rapid updates to treatment guidelines and heightened attention on MRD testing and genomic screening to identify NPM1‑mutant patients earlier.