FDA delays approval decision for Exelixis' tyrosine kinase inhibitor in colorectal cancer

Submit your nominations for the Fierce Innovation Awards - Entries close tonight Biotech FDA delays approval decision for Exelixis' tyrosine kinase inhibitor in colorectal cancer By Marissa Russo Sep 11, 2026 9:52am Exelixis PDUFA tyrosine kinase inhibitor Food and Drug Administration (FDA) The FDA has delayed its approval decision for Exelixis’ oral kinase inhibitor zanzalintinib in combination with Roche’s Tecentriq for the treatment of patients with metastatic colorectal cancer (mCRC). Exelixis explained in a Securities and Exchange Commission filing that the agency has asked for the extension while it awaits updated safety and efficacy data from the company. It means the biopharma should now expect a decision in March 2027 as opposed to the previous deadline of Dec.

3, 2026.The approval application was already on shaky ground after zanzalintinib missed one of the primary endpoints measuring overall survival in a subpopulation of a phase 3 study in mCRC patients in June. At the time, analysts at Leerink Partners and William Blair argued that the FDA would likely still approve zanzalintinib in third-line mCRC because the trial previously met the other primary endpoint of overall survival in all study participants, regardless of their liver metastases status. After zanzalintinb demonstrated significantly longer overall survival in a phase 3 head-to-head against Bayer’s gastrointestinal cancer med Stivarga last year, the drug seemed promising as a combined treatment with Roche's blockbuster anti-PD-L1 drug Tecentriq.

But that missed endpoint earlier this year punctured the hype. Analysts at William Blair told investors that they believe the risk of rejection for the zanzalintinib-Tecentriq combo remains low, due to the overall promising phase 3 data. “It is difficult to speculate the motivation behind the FDA’s request for updated safety and efficacy data,” the analysts said in a Sept.

11 note. Receptor tyrosine kinases (RTKs) are an important target for therapy because they are often dysregulated in cancer, causing aberrant cell proliferation, migration and survival. Zanzalintinib is an oral multi-targeted kinase inhibitor that acts by binding and inhibiting multiple RTKs implicated in cancer.

Exelixis has multiple other phase 3 trials running with zanzalintinib, including Stellar-311 in neuroendocrine tumors, and Stellar-304 in non-clear cell renal cell carcinoma, which is expected to read out in the second half of this year. Analysts have suggested zanzalintinib could rake in $4.5 billion in U.S. sales in 2023 across genitourinary and gastrointestinal cancers.

In the meantime, the company’s pursuit of zanalintinib in mCRC could put it in competition with drugs including Stivarga, Amgen’s Lumakras and Takeda’s Fruzaqla. Exelixis PDUFA tyrosine kinase inhibitor Food and Drug Administration (FDA) Metastatic Colorectal Cancer Roche Biotech