FDA gives priority review to Cogent’s GIST drug combination

Cogent Biosciences said the FDA has accepted its new drug application for bezuclastinib in combination with sunitinib for adults with gastrointestinal stromal tumors, or GIST, after prior imatinib treatment, and granted the filing Priority Review. The agency set a target action date of November 30, 2026. The application is backed by the phase 3 PEAK trial, which Cogent said showed the combination cut the risk of disease progression or death by 50% versus sunitinib alone, with median progression-free survival of 16.5 months versus 9.2 months. The program had already received Breakthrough Therapy designation and was submitted through the FDA’s Real-Time Oncology Review pathway. (investors.cogentbio.com)

Why it matters: This is a human oncology story, not a veterinary product update, but it may still matter to veterinary professionals who follow kinase-targeted oncology and comparative cancer biology. GIST has long relied on sequential tyrosine kinase inhibitors, with sunitinib a standard second-line option after imatinib failure or intolerance. If approved, the bezuclastinib-sunitinib combination could become the first new FDA-approved therapy in the second-line GIST setting in about two decades, potentially reshaping how KIT-mutant disease is treated and reinforcing the value of combination strategies aimed at different resistance mutations. (cancer.gov)

What to watch: Full PEAK data are being presented at ASCO on May 30, 2026, and the FDA’s decision is due by November 30, 2026. (investors.cogentbio.com)