On January 28, 2026, the U.S. Food and Drug Administration granted standard review to Exelixis’ New Drug Application for zanzalintinib in combination with atezolizumab for adult patients with metastatic colorectal cancer who have failed fluoropyrimidine-, oxaliplatin- and irinotecan-based regimens and, if RAS wild-type, anti-EGFR therapy. The Prescription Drug User Fee Act target action date is set for December 3, 2026, marking the first NDA submission for Exelixis’ novel oral kinase inhibitor in this indication.

The acceptance of the NDA is supported by phase 3 STELLAR-303 data presented at the 2025 ESMO Congress and published in The Lancet. In the global, randomized, open-label study, 451 patients received zanzalintinib plus atezolizumab and 450 received regorafenib. Zanzalintinib combination therapy achieved a statistically significant improvement in overall survival versus regorafenib in the intention-to-treat population. While data for the non-liver metastases subgroup remain immature, the trial is proceeding to a planned final OS analysis expected in mid-2026.

Zanzalintinib’s potential approval would expand Exelixis’ franchise beyond cabozantinib, leveraging its kinase inhibitor expertise across TAM kinases, MET and VEGF receptors. The company highlights a broad development plan that includes advanced solid tumors such as kidney and neuroendocrine cancers. With colorectal cancer representing approximately 159,000 new U.S. cases and 55,000 deaths expected in 2026, the addition of a novel mechanism in a market with limited post-third-line options could drive meaningful revenue growth and improve long-term pipeline valuation for value-oriented investors.