Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application
Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the company's Biologics Licence Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with CLDN18.2-positive HER2-negative gastric or GEJ adenocarcinoma. If approved, zolbetuximab would be the first CLDN18.2-targeted treatment for these patients in the United States.
The FDA has set a January 12, 2024 action date under the Prescription Drug User Fee Act (PDUFA). The FDA assessed ...
