Shots:
- The US FDA has accepted NDA & granted priority review seeking full approval of ziftomenib to treat adults with r/r acute myeloid leukemia (AML) with NPM1 mutation (PDUFA: Nov 30, 2025)
- NDA is supported by P-II (KOMET-001) trial assessing ziftomenib in r/r NPM1-mutant AML pts, which met its 1EP of CR & CR with partial hematological recovery; data to be presented at ASCO 2025 & EHA 2025
- Ziftomenib, a selective oral menin inhibitor, is being evaluated in combination with standard therapies for newly diagnosed & r/r NPM1-mutant & KMT2A-rearranged AML pts with high unmet needs
Ref: GlobeNewswire | Image: Kura Oncology and Kyowa Kirin| Press Release
Related News:- The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC
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