- In March 2025, the Food and Drug Administration (FDA) granted traditional approval for pembrolizumab (Keytruda, Merck) in combination with trastuzumab, fluoropyrimidine-, 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, ALX Oncology Holdings Inc. announced positive updated results from the ASPEN-06 Phase 2 clinical trial, showing that the company’s investigational CD47-blocker, evorpacept, produces a durable clinical response and has a well-tolerated safety profile in patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer
- In January 2025, Astellas Pharma Inc. announced that China’s National Medical Products Administration (NMPA) had 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 positive for claudin (CLDN) 18.2
- In December 2024, BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) had 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 dults whose tumors express PD-L1 (≥1)
- In August 2024, AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) received conditional approval in China as a monotherapy for treating adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have undergone two or more prior treatment regimens. This conditional approval from the National Medical Products Administration (NMPA) was based on the positive outcomes of the DESTINY-Gastric06 Phase II trial
