On August 25, 2026, the U.S. FDA approved Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) in two first-line regimens for adults with unresectable, locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma, including cancers of the stomach, gastroesophageal junction and esophagus.
The broader approval covers Ziihera combined with Tevimbra (tislelizumab-jsgr) and fluoropyrimidine- and platinum-based chemotherapy for tumors that are HER2 IHC 3+ or IHC 2+/ISH+, regardless of PD-L1 status.
A second approval covers Ziihera plus fluoropyrimidine- and platinum-based chemotherapy for HER2 IHC 3+ disease.
The decision was supported by positive Phase 3 HERIZON-GEA-01 results showing improvements in progression-free and overall survival. The FDA also approved companion diagnostic tests to identify eligible patients.
The approval moves Ziihera into the frontline setting. It previously had accelerated U.S. approval for previously treated, unresectable or metastatic HER2-positive biliary tract cancer.
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