The European Medicines Agency accepted for regulatory review Astellas Pharma’s marketing authorization application for zolbetuximab, an 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.
Patients treated with CAR T-cell medicines should be monitored life-long for secondary malignancies.
