On 9 January 2025, Astellas Pharma announced that Health Canada has approved Vyloy® (zolbetuximab for injection) 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. Canada’s Drug Agency (CDA-AMC) recently issued a draft recommendation to reimburse Vyloy™ with conditions.
The Canadian approval follows Astellas’ announcement on 6 January 2025 that China’s National Medical Products Administration (NMPA) has approved the same combination therapy for the same indication.
Vyloy® combination therapy has previously been approved in the US (October 2024), the EU and Korea (September 2024), the UK (August 2024), Japan (March 2024) and China (August 2023).