FX.co ★ Astellas Pharma : China's NMPA Approves VYLOY For Advanced Gastric/Gastroesophageal Junction Cancer

Astellas Pharma Inc. has announced the approval of VYLOY (zolbetuximab) by China's National Medical Products Administration. This approval allows the use of zolbetuximab, in conjunction with chemotherapy regimens that include fluoropyrimidine and platinum, for the initial treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma that is negative for human epidermal growth factor receptor 2 (HER2) but positive for the biomarker claudin 18.2 (CLDN18.2). Zolbetuximab stands out as the first monoclonal antibody approved by the NMPA specifically targeting gastric tumor cells expressing CLDN18.2. Astellas has already integrated the financial implications of zolbetuximab's approval into its fiscal forecast for the year ending March 31, 2025.