BeOne Medicines Announces U.S. FDA Approval for TEVIMBRA-Based Regimen for First-Line HER2+ GEA
TEVIMBRA plus ZIIHERA and chemotherapy is the first and only immunotherapy-based regimen to deliver more than two years of median OS in first-line HER2+ GEA, regardless of PD-L1 status
Regimen poised to become standard of care in this difficult-to-treat disease.
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive (HER2+) gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA). The approval is supported by results from the Phase 3 HERIZON-GEA-01 trial, which were published in The New England Journal of Medicine earlier this year.
GEA, which includes adenocarcinomas of the stomach, gastroesophageal junction and esophagus, remains an area of substantial unmet need in the United States, with more than 31,000 new stomach cancer cases diagnosed each year.1 Approximately 20% of patients with GEA have HER2+ disease, a subtype that has historically been difficult to treat.2,3,4
