The FDA approved Kura Oncology and Kyowa Kirin’s oral menin inhibitor ziftomenib (Komzifti) for relapsed/refractory NPM1-mutant acute myeloid leukemia based on phase II single-arm data. Regulatory filings and company commentary cited durable complete remissions, measurable residual disease (MRD) negativity in responders, and a tolerable safety profile; differentiation syndrome was observed and managed. The approval positions Komzifti against existing NPM1-targeted therapies and underscores the agency’s willingness to grant full approvals on pivotal single-arm datasets in high-unmet-need hematologic malignancies. Analysts flagged potential market competition and convenience advantages cited by Kura.