FDA pushes back decision on Exelixis' zanzalintinib and Roche's Tecentriq combo for metastatic colorectal cancer

The FDA announced a delay in its decision on the approval of Exelixis' oral kinase inhibitor zanzalintinib when used with Roche's Tecentriq for metastatic colorectal cancer.

The agency said it needs additional safety and efficacy data, moving the expected decision date to March 2027, later than the original Dec 3, 2026 deadline.

The application was already challenged after zanzalintinib missed a primary overall survival endpoint in a subpopulation of a phase 3 trial, though it met the overall survival endpoint for the full study population.

Analysts had previously suggested the drug might still receive approval in the third‑line setting because of its overall survival benefit and prior head‑to‑head data against Bayer's Stivarga.

The delay adds uncertainty for Exelixis and investors as the company awaits the FDA's final review.