AUG 30 2026
BeOne Medicines Ltd. — Tevimbra (Tevimbra) $ONC
for first-line HER2-positive gastroesophageal adenocarcinoma
FDA approves Tevimbra-based regimen for first-line treatment of HER2-positive gastroesophageal adenocarcinoma.
About
Tevimbra is an antibody that blocks a protein called PD-1, which some cancers use to hide from the body's immune system. By blocking PD-1, Tevimbra helps the immune system recognize and attack cancer cells. When combined with chemotherapy, this approach may offer a new initial treatment option for this aggressive form of stomach and esophageal cancer.
Pivotal trial
This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Tevimbra
- BeOne Medicines Announces U.S. FDA Approval for TEVIMBRA-Based Regimen for First-Line HER2+ GEA - Via TT
- BeOne Medicines Receives Positive Reimbursement Recommendations from CDA-AMC and INESSS for TEVIMBRA in First-Line Nasopharyngeal Carcinoma - PR Newswire Canada
- Tevimbra/Ziihera combination granted priority review to treat gastric cancer - Managed Healthcare Executive
- ZIIHERA Plus TEVIMBRA and Chemotherapy: A Potential New Standard for First-Line HER2+ Advanced GEA - BioSpace
- Health Canada Approves TEVIMBRA® (tislelizumab for injection) in Combination with Gemcitabine and Cisplatin for the First-Line Treatment of Adult Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma - BioSpace