Bezuclastinib + sunitinib
Gastrointestinal stromal tumors after prior imatinib · Patients with gastrointestinal stromal tumors who received prior treatment with imatinib
COGT · Cogent Biosciences
Regulatory designations
Full timeline
6 milestonesFDA decision expected
FDA assigned a November 30, 2026 PDUFA target action date to the bezuclastinib combination NDA.
Cogent — NDA acceptance and PDUFA date↗Detailed Phase 3 PEAK results were presented
The combination achieved median progression-free survival of 16.5 months versus 9.2 months with sunitinib alone and an objective response rate of 46% versus 26%.
Cogent — Detailed PEAK results at ASCO 2026↗FDA accepted the NDA with Priority Review
FDA accepted the application under review following the Phase 3 PEAK results and said it did not then plan an advisory committee meeting.
Cogent — NDA acceptance and Priority Review↗FDA granted Breakthrough Therapy designation
FDA granted Breakthrough Therapy designation for bezuclastinib plus sunitinib in GIST after prior imatinib.
Cogent — Breakthrough Therapy designation↗Related News
Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2026 Financial Results
Oct 27, 2026Cogent Biosciences to Participate in the Guggenheim Healthcare Innovation Conference
Sep 15, 2026Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
Aug 10, 2026Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results
Jun 30, 2026Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)