Posted by Michael Wonder on 03 Feb 2026
Exelixis announces US FDA accepted the new drug application for zanzalintinib in combination with an immune checkpoint inhibitor for patients with metastatic colorectal cancer
2 February 2026 - Exelixis today announced that its new drug application for zanzalintinib, in combination with atezolizumab (Tecentriq), has been accepted for review in the US for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor therapy.
The FDA assigned a standard review with a PDUFA target action date of 3 December 2026.
