Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST
Cogent Biosciences announced that the FDA has accepted its New Drug Application for bezuclastinib in combination with sunitinib for GIST patients, granting Priority Review with a PDUFA date of November 30, 2026. The FDA noted no plans for an advisory committee and identified no potential review issues, signaling a smooth regulatory path for the company's lead asset. The NDA is supported by Phase 3 PEAK trial data showing a 50% reduction in disease progression risk (HR 0.50) and median PFS of 16.5 months versus 9.2 months for sunitinib alone.
Key figures
- Drug Name
- bezuclastinib
- Phase Of Trial
- Phase 3
- Pdufa date
- November 30, 2026
- Hazard ratio
- 0.5
- Or R combination
- 46%
- Or R monotherapy
- 26%
- Pfs combination
- 16.5 months
- Pfs monotherapy
- 9.2 months
AI analysis
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