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Jump to Key Points Sept 11 (Reuters) - The U.S. Food and Drug Administration has extended the review of Exelixis' experimental colorectal cancer drug combination by three months, the company said in a filing on Friday.
The regulator will now make its decision by March 3, 2027.
Shares of the company slipped about 3.5% before the bell.
In response to an FDA information request, Exelixis submitted updated safety and efficacy data, which the health regulator classified as a major amendment, the filing showed.
- FDA review of zanzalintinib+atezolizumab extended 3 months.
- New decision date set for March 3, 2027.
- FDA classified updated safety/efficacy data as major amendment.
- Indication sought: previously treated adult metastatic colorectal cancer subset.
- June phase 3 data: one OS endpoint missed significance; another showed OS benefit.
The drugmaker did not immediately respond to a Reuters request for further details.
The company is seeking approval for zanzalintinib in combination with Roche's immunotherapy Tecentriq for the treatment of a subset of adult patients with metastatic colorectal cancer who have been previously treated.
Analysts see zanzalintinib as a key growth driver for Exelixis, extending the company's cancer franchise beyond its older drug Cabometyx.
"While we are surprised by the three-month delay... we believe the risk of rejection remains low," said William Blair analyst Andy Hsieh.
Zanzalintinib is an oral drug belonging to the class known as tyrosine kinase inhibitors that selectively inhibit protein kinases that regulate cell growth.
In June, the combination failed to achieve statistical significance in a late-stage trial on one of two main goals measuring overall survival in patients without active liver metastases.
In another trial reported in June 2025, the combo showed statistically significant improvement in overall survival compared to Bayer's Stivarga in the intent-to-treat population of patients.
Intent-to-treat patients represent the largest commercial opportunity within the target population, William Blair analysts wrote in a note last month.
The company is also studying zanzalintinib in other types of cancer.
(Reporting by Sriparna Roy in Bengaluru; Editing by Vijay Kishore)
