FDA extends Exelixis zanzalintinib review by three months

Exelixis, Inc. (NASDAQ: EXEL) announced that the U.S. Food and Drug Administration has extended the review period for its new drug application for zanzalintinib, in combination with atezolizumab, for the treatment of metastatic colorectal cancer by three months.

The FDA notified Exelixis of the extension on September 10, 2026. The agency classified the extension as a major amendment, prompted by updated safety and efficacy data that Exelixis submitted in response to an FDA information request.

The updated Prescription Drug User Fee Act action date is now March 3, 2027.

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