- In March 2025, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) in combination with trastuzumab, fluoropyrimidine-based chemotherapy, and platinum-based chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 (CPS ≥1).
- In January 2025, Astellas Pharma Inc. announced that China’s National Medical Products Administration (NMPA) has approved VYLOY (zolbetuximab) in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors are claudin (CLDN) 18.2 positive. Zolbetuximab is the first monoclonal antibody approved by the NMPA that targets gastric tumor cells expressing the CLDN18.2 biomarker, providing a highly targeted approach to cancer treatment.
- In January 2025, Astellas Pharma Canada Inc. announced that Health Canada has approved VYLOY (zolbetuximab for injection) for use in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors are claudin (CLDN) 18.2 positive, as determined by a validated test. In addition, the company is pleased to report that Canada’s Drug Agency (CDA-AMC) has recently issued a draft recommendation for conditional reimbursement of VYLOY.
- In December 2024, BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) approved TEVIMBRA (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in adults whose tumors express PD-L1 (≥1).
- In June 2023, Merck announced the topline results from the Phase 3 KEYNOTE-585 trial, which investigated the use of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, followed by adjuvant treatment with KEYTRUDA plus chemotherapy, and then KEYTRUDA monotherapy in patients with locally advanced resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma.
