The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
NOV 30 2026
UPCOMING · 62 DAYS TO PDUFA

Cogent Biosciences — bezuclastinib $COGT

for imatinib-resistant gastrointestinal stromal tumor (GIST)

NDA · Priority Review · Breakthrough

Accepted MAY 28 2026.

About

Gastrointestinal stromal tumors are the most common connective-tissue cancers of the digestive system, driven primarily by mutations in the KIT gene. Bezclastinib is a small-molecule pill designed to selectively block the specific mutated KIT protein that fuels these tumors. By precisely targeting this driver mutation, the drug could potentially control tumor growth in patients who have stopped responding to prior therapies.

Pivotal trial

NCT05208047 Phase 3 recruiting NCT05208047

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients

Source: ClinicalTrials.gov

Also in development