BeOne says FDA approves Tevimbra-based first-line regimen for HER2+ gastroesophageal cancer
ONC•HERIZON-GEA-01 efficacy results
HERIZON-GEA-01 showed median overall survival of 26.4 months versus 19.2 months for trastuzumab with chemotherapy.
Median progression-free survival reached 12.4 months versus 8.1 months; benefit held across PD-L1 subgroups.
FDA approves Tevimbra-based first-line regimen
The U.S. FDA cleared TEVIMBRA (tislelizumab) with ZIIHERA (zanidatamab) and chemotherapy for first-line HER2-positive advanced gastric cancers.
The label covers unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma in adults.
