FDA Approves Ziihera Regimens for HER2-Positive Gastroesophageal Cancer

The FDA has approved two new Ziihera (zanidatamab-hrii) regimens for first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma. This marks the first bispecific HER2-directed antibody for this indication. A Phase 3 trial showed Ziihera plus tislelizumab and chemotherapy extended median overall survival to 26.4 months, reducing death risk by 28% compared to trastuzumab plus chemotherapy. This offers a significant new option for patients facing this aggressive cancer.