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# FDA Accepts Exelixis NDA for Metastatic Colorectal Cancer
- URL: https://www.fdaweb.com/fda-accepts-exelixis-nda-for-metastatic-colorectal-cancer/
- Published: 2026-02-02T12:00:00.000Z
- Updated: 2026-09-14T15:32:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160588

FDA has accepted for review an Exelixis NDA for zanzalintinib in combination with the immune checkpoint inhibitor atezolizumab for patients with previously treated metastatic colorectal cancer. The application is seeking approval for treating adult patients with metastatic colorectal cancer who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-EGFR therapy, according to the company. The agency has set a 12/3 user fee review action target date.

The NDA is based on results from the phase 3 STELLAR-303 trial. In the intention-to-treat population, the combination therapy demonstrated a statistically significant improvement in overall survival and a reduction in the risk of death compared with regorafenib, the company says.

Zanzalintinib is described as an investigational oral kinase inhibitor targeting TAM kinases, MET and VEGF receptors. Exelixis is developing the drug across multiple solid tumor indications, including colorectal cancer, kidney cancer and neuroendocrine tumors.