FDA delays decision on Exelixis' colorectal cancer drug zanzalintinib
Rule ChangesThree-month extension moves the PDUFA decision to March 2027
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Overview
Updated 1 hour agoExelixis learned on September 10 that the FDA would delay its decision on zanzalintinib, its experimental colorectal cancer drug, by three months. The new deadline is March 3, 2027, after the agency deemed updated safety and efficacy data a major amendment to the application.
The drug, paired with Roche's immunotherapy atezolizumab (Tecentriq), is Exelixis' best chance at a second franchise after the blockbuster Cabometyx. If approved, it would be the first immunotherapy-based regimen to show an overall survival benefit in metastatic colorectal cancer patients who are not MSI-high, the large majority of cases.
Why it matters
The FDA's March 2027 decision determines whether Exelixis launches its next cancer drug or cedes ground to regorafenib and fruquintinib in late-line colon cancer.
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Organizations Involved
Alameda-based developer of the investigational kinase inhibitor zanzalintinib.
The agency deciding whether zanzalintinib can be marketed in the United States.
Partner to Exelixis, providing the PD-L1 checkpoint inhibitor in the combination under review.
Timeline
October 2025 September 2026
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Exelixis discloses delay; shares slip
Today RegulatoryExelixis files with SEC; shares fall about 2%. New decision date is March 3, 2027.
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FDA notifies Exelixis of three-month extension
RegulatoryFDA tells Exelixis it will extend the review after updated data filed.
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Secondary analysis misses statistical bar
Trial ResultsAnalysis in patients without liver metastases shows non-significant survival trend, hazard ratio 0.83.
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FDA accepts new drug application
RegulatoryFDA accepts Exelixis' application covering previously treated metastatic colorectal cancer patients.
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STELLAR-303 results presented at ESMO Congress
Trial ResultsPhase III trial shows zanzalintinib plus atezolizumab improves overall survival versus regorafenib.
Historical Context
2 moments from history that rhyme with this story — and how they unfolded.
Regorafenib (Stivarga) approval (2012)
The FDA approved regorafenib as the first treatment for metastatic colorectal cancer that had progressed after standard therapy. Approval rested on the CORRECT trial, where the drug extended median overall survival from 5.0 to 6.4 months.
Regorafenib became the standard third-line option and remains one today.
It set the benchmark for late-line colon cancer drugs and is the comparator arm in Exelixis' STELLAR-303 trial.
Zanzalintinib was tested directly against regorafenib, and the 1.5-month median survival advantage it showed echoes the modest benefits the FDA has accepted in this exact setting.
Fruquintinib (Fruzaqla) approval (2023)
The FDA approved fruquintinib, a vascular endothelial growth factor receptor inhibitor, for refractory metastatic colorectal cancer based on the global FRESCO-2 trial showing median overall survival of 7.4 months versus 4.8 months with placebo.
Fruquintinib gave US patients a new oral option in late-line colon cancer.
It joined regorafenib and trifluridine/tipiracil as one of the approved options zanzalintinib would compete with.
The FDA has approved multiple kinase inhibitors in this space despite modest survival gains, suggesting approval odds for zanzalintinib remain meaningful even with imperfect secondary data.
