On 20 September 2024, Astellas Pharma announced that the European Commission 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 tumours are claudin (CLDN) 18.2 positive. European approval of Vyloy™ follows its recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in July this year.
The Korea Biomedical Review has also recently reported that Vyloy™ has been approved for the same indication in Korea.
Vyloy™ is said to be the first therapy worldwide to target Claudin 18.2, a protein expressed in the stomach, and has previously been approved in the UK (August 2024), Japan (March 2024) and China (August 2023).