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.
GSK5764227 (GSK’227), a B7-H3-targeted antibody-drug conjugate, has received Orphan Drug Designation from the European Medicines Agency for the treatment of pulmonary neuroendocrine carcinoma, a category of cancer that includes small-cell lung cancer.
