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 European Commission approved Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.
