— Bispecific antibody plus chemo with or without tislelizumab improves OS, PFS versus trastuzumab

August 25, 2026

• 2 min read

The FDA approved zanidatamab (Ziihera) plus tislelizumab (Tevimbra) and chemotherapy as first-line treatment for unresectable/metastatic HER2-positive gastroesophageal cancer.

The approval stipulates use in adults with unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma with HER2 positivity confirmed by an FDA-approved test. The approval allows use of zanidatamab plus platinum-containing chemotherapy with or without tislelizumab. At the same time the agency approved two diagnostic tests to identify patients who are candidates for zanidatamab, a HER2-targeting bispecific antibody.