Shots:
- The US FDA has accepted NDA & granted priority review to Cogent‘s bezuclastinib + sunitinib for the treatment of pts with GIST who were treated with imatinib, with no advisory committee meeting planned yet (PDUFA: Nov 30, 2026)
- NDA was supported by the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx. in pts with imatinib-resistant or intolerant GIST
- As of Sep 30, 2025, trial met its 1EP of improved PFS, reducing risk of disease progression or death by 50% (mPFS: 16.5 vs 9.2mos.) & showed ORR of 46% vs 26%; OS data remains immature. Data to be presented at ASCO’26
Ref: Globenewswire | Image: Cogent Biosciences | Press Release
Related News: Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)
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