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FDA extends review period for Exelixis' zanzalintinib NDA to March 3, 2027 after major amendment request
EXELExelixis, Inc.
Exelixis announced that the FDA extended the review period for its new drug application (NDA) for zanzalintinib, in combination with atezolizumab, to treat metastatic colorectal cancer. The extension was triggered by an FDA information request regarding updated safety and efficacy data submitted by Exelixis, which the agency classified as a major amendment. Consequently, the new Prescription Drug User Fee Act (PDUFA) action date is March 3, 2027. This regulatory delay impacts the timeline for potential commercialization of the drug candidate. Exelixis operates in the biotechnology industry, focusing on the discovery and development of targeted therapies for cancer.