Astella's Vyloy Approved in China for HER2-Negative Gastric Cancer

Astellas Pharma Inc. announced that China’s National Medical Products Administration (NMPA) has given the approval to Vyloy (zolbetuximab), in conjunction with fluoropyrimidine- and platinum-based chemotherapy, for the initial treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric treatment or gastroesophageal junction (GEJ) adenocarcinoma with claudin (CLDN) 18.2 positive tumors.

Gastric cancer ranks as the third highest cause of cancer deaths in China, with over 260,000 fatalities attributed to the disease in 2022. Due to the difficulty in recognizing early symptoms, around 60% of Chinese patients receive diagnoses during the advanced phase of the disease6 when treatment choices are restricted and results are frequently unfavorable.

Professor Xu Ruihua, lead primary investigator of the phase 3 GLOW study, director of the cancer prevention and treatment center of Sun Yat-sen University, President of the Chinese Society of Clinical Oncology (CSCO): “Approximately 30% of patients enrolled in the global phase 3 GLOW trial were from mainland China. The results of this study demonstrated that the combination of zolbetuximab and chemotherapy provided significant survival benefits to patients with CLDN18.2-positive, HER2-negative advanced gastric and gastroesophageal junction (GEJ) cancers. The analysis of the China subgroup data showed that Chinese gastric cancer patients benefited substantially in terms of both survival and quality of life. We are excited that the NMPA has approved zolbetuximab, which will provide a valuable and effective first-line treatment option for patients with advanced gastric cancer in China.”