Exelixis provided update n new drug application (NDA) for zanzalintinib

On September 11, 2026 Exelixis reported that the U.S. Food and Drug Administration (FDA) notified about extending the review period for Exelixis’ new drug application (NDA) for zanzalintinib, in combination with atezolizumab, for the treatment of patients with metastatic colorectal cancer by three months. In response to an FDA information request, Exelixis had submitted updated safety and efficacy data, which the FDA has deemed a major amendment. The updated Prescription Drug User Fee Act action date is March 3, 2027.

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(Press release, Exelixis, SEP 11, 2026, View Source [SID1234670750])