FDA extends review of Exelixis' zanzalintinib+atezolizumab NDA for mCRC by 3 months

EXELIXIS, INC.

FDA deemed submitted safety/efficacy data a major amendment; PDUFA date extended to March 3, 2027.
Extension triggered by Exelixis' response to FDA information request for the metastatic colorectal cancer NDA.
Zanzalintinib combined with atezolizumab is under review for patients with metastatic colorectal cancer.
No change to existing approved products; delay adds 3 months to regulatory decision timeline.

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