Cogent Biosciences' bezuclastinib NDA for GIST accepted with Priority Review
Cogent Biosciences announced that the FDA has accepted its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior imatinib treatment. The FDA granted Priority Review with a PDUFA target action date of November 30, 2026, and currently has no plans for an advisory committee. This follows positive Phase 3 PEAK trial results demonstrating a median Progression-Free Survival (PFS) of 16.5 months versus 9.2 months for sunitinib alone, and an Objective Response Rate (ORR) of 46% versus 26%. Full results will be presented at ASCO this weekend.
Key Highlights
- FDA accepted NDA for bezuclastinib in combination with sunitinib for GIST patients previously treated with imatinib.
- FDA granted Priority Review for the application.
- PDUFA target action date set for November 30, 2026.
- No advisory committee planned and no potential review issues identified by FDA.
- Phase 3 PEAK trial showed median PFS of 16.5 months for combination vs 9.2 months for sunitinib alone (HR=0.50, p<0.0001).
- Objective Response Rate (ORR) was 46% for the bezuclastinib combination vs 26% for sunitinib alone.
- Full PEAK trial results to be shared in an oral presentation at ASCO on Saturday, May 30, 2026.
Price Impact
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