FDA Delays Cancer Drug Decision
FDA Extends Review of Exelixis Cancer Drug Combination to March 2027
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Key Points
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The FDA had previously been expected to act on Exelixis’ application by early December 2026, before setting the new March 3, 2027 target date.
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The application covers zanzalintinib in combination with Tecentriq, Roche’s/Genentech’s immunotherapy, for a subset of adults with metastatic colorectal cancer.
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Zanzalintinib is a next-generation tyrosine kinase inhibitor that Exelixis is also developing for other advanced solid tumors, including kidney cancer and neuroendocrine tumors.
The FDA has pushed back its decision on Exelixis' cancer drug zanzalintinib by three months, moving the expected approval date to March 3, 2027. Endpoints News reported that the agency classified the company's updated safety and efficacy data as a major amendment, requiring additional review time. The delay means patients with metastatic colorectal cancer will wait longer for potential access to the treatment.
Stock Falls on Unexpected Three-Month Delay
Exelixis shares dropped 2% after the FDA announcement, Yahoo Finance reported. The company had expected a regulatory decision by early December 2026, but the new action date extends the timeline significantly. William Blair analysts flagged the possibility of more stock volatility in the near term as investors digest the setback.
What The Drug Combination Treats
Zanzalintinib is being tested with Tecentriq, a Roche immunotherapy drug, to treat adults with metastatic colorectal cancer — cancer that has spread beyond the colon. Fierce Biotech noted that zanzalintinib is an oral tyrosine kinase inhibitor, a type of targeted cancer drug that blocks specific proteins driving tumor growth. The combination targets a specific subset of patients in this hard-to-treat cancer category.
Exelixis Pursuing Zanzalintinib in Other Cancers Too
Beyond colorectal cancer, Exelixis is developing zanzalintinib for kidney cancer and neuroendocrine tumors — both advanced solid tumors where the drug showed potential. The three-month extension gives the FDA more time to evaluate the safety data and ensure the drug meets approval standards. This delay affects only the colorectal cancer indication covered in the current application.
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