The U.S. Food and Drug Administration (FDA) has extended its review of Exelixis’ application for zanzalintinib in combination with Roche’s immunotherapy Tecentriq for certain previously treated adult patients with metastatic colorectal cancer (mCRC), according to company disclosures released Friday.
The agency’s decision is now expected by March 3, 2027, three months later than the previously scheduled action date of Dec. 3, 2026. Exelixis said the extension followed an FDA request for updated safety and efficacy information, which the regulator classified as a major amendment to the application. The company submitted the requested data in response to the agency’s inquiry.
Shares of Exelixis fell about 3.5% in premarket trading following the announcement.
FDA Extends Timeline After Major Amendment Submission
Exelixis disclosed in a filing with the U.S. Securities and Exchange Commission that the FDA requested updated safety and efficacy data related to the application. The regulator classified the submission as a major amendment, extending the review period by three months.
The company is seeking approval of zanzalintinib together with Tecentriq for a subset of adult patients with metastatic colorectal cancer who have previously received treatment.
Exelixis did not immediately respond to a request for additional details regarding the FDA’s information request.
Late-Stage Trial Results Form Part of the Review
The application follows mixed results from studies evaluating the treatment combination. In June, a late-stage trial of zanzalintinib and Tecentriq did not achieve statistical significance on one of its two primary endpoints measuring overall survival among patients without active liver metastases.
Analysts at Leerink Partners and William Blair argued at the time that the FDA would likely still approve the combination in third-line metastatic colorectal cancer because the study had previously met its other primary endpoint measuring overall survival across all study participants, regardless of liver metastasis status.
The combination also produced positive findings in another phase 3 study reported in June 2025. In that trial, zanzalintinib and Tecentriq demonstrated a statistically significant improvement in overall survival compared with Bayer’s Stivarga in the intent-to-treat patient population.
William Blair analysts wrote last month that the intent-to-treat population represents the largest commercial opportunity within the target patient group.
Analysts Comment on the FDA Decision
Analysts at William Blair said they were surprised by the review extension but maintained a positive view of the application.
“While we are surprised by the three-month delay… we believe the risk of rejection remains low,” said William Blair analyst Andy Hsieh.
In a Sept. 11 note, William Blair analysts stated that they believe the risk of rejection remains low because of what they described as promising phase 3 data. The analysts also said it was difficult to speculate on the motivation behind the FDA’s request for updated safety and efficacy data.
Development Program Continues in Other Cancer Types
Zanzalintinib is an oral kinase inhibitor that targets multiple receptor tyrosine kinases involved in cancer. According to the information provided by Exelixis, receptor tyrosine kinases are often dysregulated in cancer and can contribute to abnormal cell proliferation, migration and survival.
Beyond metastatic colorectal cancer, Exelixis is evaluating zanzalintinib in several additional phase 3 studies. These include the Stellar-311 trial in neuroendocrine tumors and the Stellar-304 trial in non-clear cell renal cell carcinoma, which is expected to report results during the second half of this year.
Analysts have described zanzalintinib as a key growth driver for Exelixis that could extend the company’s cancer franchise beyond Cabometyx.
Exelixis Faces Extended FDA Review for Cancer Treatment
Exelixis has announced that the U.S. Food and Drug Administration has extended its review of the company’s application for a combination of zanzalintinib and Tecentriq (atezolizumab) for patients with metastatic colorectal cancer.
The combination is being evaluated as a potential treatment option for patients with advanced colorectal cancer. The extended review gives the FDA additional time to complete its assessment of the application and supporting clinical data.
For Exelixis, the regulatory decision represents an important milestone in the development of zanzalintinib. The company is continuing to work with regulators as the review progresses.
Exelixis and Zanzalintinib Development
Zanzalintinib is an investigational tyrosine kinase inhibitor being studied across multiple cancer types. Exelixis has been evaluating the medicine in combination with other therapies as part of its broader oncology development strategy.
An extended FDA review does not itself indicate whether regulators will approve or reject a medicine. It means the agency requires additional time to complete its evaluation of the application.
Exelixis will continue engaging with the FDA throughout the review process. Further regulatory updates are expected to provide more information about the application and the potential future use of the combination.
What Comes Next for Exelixis
The FDA’s final decision will be closely watched by Exelixis, healthcare professionals, and the oncology community. If approved, the combination could add another treatment option for certain patients with metastatic colorectal cancer.
Until the regulatory process is complete, the potential role of the Exelixis combination will depend on the FDA’s assessment of the available clinical evidence.
Exelixis Expands Its Oncology Pipeline
Exelixis continues to advance its oncology pipeline through research focused on targeted therapies and combination treatment approaches. The development of zanzalintinib reflects Exelixis’ broader efforts to investigate medicines that may address significant unmet needs in cancer care.
The FDA review extension gives regulators additional time to evaluate the submitted data. For Exelixis, the review process is an important part of determining whether the zanzalintinib-Tecentriq combination can potentially become available for eligible patients with metastatic colorectal cancer.
Exelixis and Combination Therapy Research
Cancer treatment increasingly involves combinations designed to target tumors through different mechanisms. Exelixis is studying zanzalintinib alongside other therapies to understand whether these approaches can provide meaningful clinical benefits.
Tecentriq is an immune checkpoint inhibitor that targets the PD-L1 pathway. Combining immunotherapy with a targeted treatment such as zanzalintinib represents an area of ongoing oncology research.
For Exelixis, clinical evidence from these studies is essential for understanding the treatment’s potential benefits and risks. Researchers must evaluate factors including response rates, progression-free survival, overall survival, and safety outcomes.
Metastatic Colorectal Cancer Treatment Landscape
Metastatic colorectal cancer occurs when colorectal cancer has spread to other parts of the body. Treatment options can include chemotherapy, targeted therapies, immunotherapy, and other approaches depending on factors such as tumor characteristics and previous treatments.
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