U.S. FDA Acknowledges Astellas' Resubmission of Biologics License Application for Zolbetuximab and Sets New Action Date

Astellas' resubmission of the Biologics License Application (BLA) for zolbetuximab, a CLDN18.2-targeted monoclonal antibody for first-line treatment of HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, has been acknowledged by the U.S. FDA, setting a new action date of November 9, 2024.