The European Medicines Agency (EMA) has accepted for regulatory review Astellas Pharma’s marketing authorisation application (MAA) for zolbetuximab, an investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody. The application is for authorisation as a first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are CLDN18.2-positive. Gastric cancer […]
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