FDA has accepted and the Biologics License Application for zolbetuximab, a first-in-class investigational Claudin 18.2-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
