The FDA extended its review of Exelixis’s zanzalintinib, an investigational tyrosine kinase inhibitor, by three months.
The drug is being reviewed in combination with Roche/Genentech’s atezolizumab (Tecentriq) for adults with previously treated metastatic colorectal cancer.
The new Prescription Drug User Fee Act (PDUFA) decision date is March 3, 2027, moved from December 3, 2026.
The extension followed Exelixis’s submission of updated safety and efficacy data that the FDA classified as a major amendment to the application.
The company said the delay was procedural; no specific new safety or efficacy concern was disclosed. Analysts cited continued approval prospects but expect increased near-term volatility in Exelixis shares.
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