<p>Exelixis Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zanzalintinib in combination with atezolizumab (Tecentriq®) for the treatment of adult patients with metastatic colorectal cancer who have previously received standard chemotherapy and, if RAS wild-type, an anti-EGFR therapy. The application is supported by results from the phase 3 STELLAR-303 trial, which showed a statistically significant improvement in overall survival compared to regorafenib. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026. The final analysis of the trial’s secondary endpoint is expected in mid-2026. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Exelixis Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260130221586) on February 02, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)</p>

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<p>Exelixis Inc. announced that the FDA has accepted its NDA for zanzalintinib in combination with atezolizumab for treating metastatic colorectal cancer in adults who have previously undergone standard chemotherapy. The application is based on the phase 3 STELLAR-303 trial results, which indicated a significant improvement in overall survival compared to regorafenib. The FDA has set a PDUFA target action date of December 3, 2026, with the final analysis of the trial's secondary endpoint expected in mid-2026.</p>

Reuters

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FDA Accepts Exelixis Application for Zanzalintinib Combination in Metastatic Colorectal Cancer