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Approval Alert: FDA Approves Astellas Pharma’s Zolbetuximab

Oct 18, 2024

On 18 October 2024, Astellas Pharma announced that the FDA has approved Vyloy™ (zolbetuximab-clzb) 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.  Vyloy™ is the first CLDN18.2-targeted therapy approved in the U.S.

The US approval follows September 2024 approvals for the same Vyloy™ combination in Europe and Korea.  Vyloy™ has previously been approved in the UK (August 2024), Japan (March 2024) and China (August 2023).