Shots:
- The US FDA has granted full approval to Komzifti (QD, PO) to treat adults with r/r AML with NPM1 mutation who have no satisfactory alternative treatment options before the PDUFA date of Nov 30, 2025
- Approval was backed by P-I/II (KOMET-001) trial in 112 r/r NPM1-mutant AML pts, showing 21.4% CR + CRh with a median duration of 5mos., & a median time to first response of 2.7mos. in those who achieved CR or CRh, with 88% responding within 6mos.; data published in The JCO
- In Nov 2024, Kura & Kyowa formed a global collaboration for Komzifti, with Kura leading US development, regulatory, commercialization, & manufacturing, jointly handling some US commercialization activities, while Kyowa Kirin leads all strategy & commercialization outside the US
Ref: Kura Oncology | Image: Kura Oncology and Kyowa Kirin| Press Release
Related News:- Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia
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