FDA Extends Review of Exelixis' Zanzalintinib in Colorectal Cancer
By Colin Kellaher
Exelixis said the Food and Drug Administration has extended its review of the company's proposed zanzalintinib cancer drug by three months.
Exelixis, which is seeking FDA approval zanzalintinib in combination with Genentech's cancer drug Tecentriq for patients with metastatic colorectal cancer, said it recently submitted updated safety and efficacy data, which the FDA deemed a major amendment to the Alameda, Calif., oncology company's application.
The FDA, which had been expected to act on the application by early December, set a new target action date of March 3, 2027, Exelixis said.
Zanzalintinib, Exelixis' next-generation tyrosine kinase inhibitor, is in development for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer and neuroendocrine tumors.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 11, 2026 07:50 ET (11:50 GMT)
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