Shots:
The US FDA has approved the sBLA for Tevimbra (tislelizumab) + Ziihera (zanidatamab) & CT for the 1L treatment of adults with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA)
Approval was based on the P-III (HERIZON-GEA-01) assessing the efficacy & safety of Ziihera+ CT, with and without Tevimbra, to the…
Shots:
FDA has granted priority review to BeOne's Tevimbra + Ziihera & CT for the 1L treatment of unresectable locally advanced/metastatic HER2+ gastric, GEJ, or esophageal adenocarcinoma; BeOne plans to participate in the FDA’s Project Orbis
sBLA was based on the P-III (HERIZON-GEA-01) trial, which assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as…

