By Fineline Cube 
Japan-based Astellas Pharma Inc. (TYO: 4503) announced that the first prescriptions for Vyloy (zolbetuximab) in combination with fluoropyrimidine and platinum-based chemotherapy have been issued across 27 provinces and municipalities in China. This marks the official clinical adoption of China’s first innovative first-line treatment for CLDN18.2-positive, HER2-negative advanced gastric cancer.
Drug Approval and Indication
Vyloy was approved by China’s National Medical Products Administration (NMPA) in December 2024. It is indicated for first-line therapy in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Clinical Trial Results
Data from two Phase III clinical trials, GLOW and SPOTLIGHT, demonstrated that zolbetuximab-based therapy significantly improved progression-free survival (PFS) and overall survival (OS) compared to standard chemotherapy in eligible gastric/GEJ adenocarcinoma patients. In the GLOW study, median PFS was 8.21 months and median OS was 14.39 months. In the SPOTLIGHT study, median PFS was 10.61 months and median OS was 18.23 months, both significantly surpassing the control group.-Fineline Info & Tech