Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, „Astellas“) today announced that the European Commission (EC) has approved VYLOY™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. The European Medicines Agency has recommended that zolbetuximab’s designation as an orphan medicinal product be maintained in recognition of the poor survival outcomes associated with gastric and GEJ cancers.
Zolbetuximab is currently the first and only approved monoclonal antibody specifically designed to target gastric tumor cells that express the biomarker CLDN18.2, offering a more personalized approach to cancer treatment. In the zolbetuximab Phase 3 clinical trials, approximately 38% of adult patients with advanced and metastatic gastric and GEJ cancers had tumors that were CLDN18.2 positive.1,2 By binding to CLDN18.2 expressed on tumor cell membranes, zolbetuximab results in antibody-dependent cellular cytotoxicity, complement dependent cytotoxicity and tumor growth inhibition.3
