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FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma
On August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals):
- in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.), as first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test, and
- in combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test.
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