Kura and Kyowa’s Komzifti moves ahead at pace in US market

27 November 2025

US biotech Kura Oncology (Nasdaq: KURA) and Japanese specialty pharma Kyowa Kirin (TYO: 4151) have secured early guideline recognition for Komzifti (ziftomenib), their new treatment for a subset of adults with relapsed or refractory acute myeloid leukemia.

Komzifti, the first and only once-daily oral menin inhibitor approved for adults with relapsed or refractory acute myeloid leukemia harboring a susceptible NPM1 mutation and no satisfactory alternatives, has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology.

The NCCN listing names Komzifti as a Category 2A recommended option for adults with relapsed or refractory acute myeloid leukemia and NPM1 mutation. The guidance arrives less than two weeks after the American medicines regulator granted full approval on November 13, 2025.

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