FDA extends Exelixis colorectal cancer drug review by three months

  • FDA extended Exelixis’ review of a zanzalintinib-based colorectal cancer treatment combination.
  • March 3, 2027, is the regulator’s new deadline for its decision.
  • Exelixis submitted updated safety and efficacy data after an FDA information request.

The U.S. Food and Drug Administration (FDA) has extended its review of Exelixis’ experimental colorectal cancer drug combination by three months, with a decision now due by March 3, 2027. Exelixis submitted updated safety and efficacy data in response to an FDA information request, and the agency classified the submission as a major amendment. The company is seeking approval for zanzalintinib with Roche’s Tecentriq immunotherapy for a subset of adults with metastatic colorectal cancer.

The information on this website is generated using AI and we cannot guarantee its accuracy. Please use it as reference information only.