FDA Approves Ziihera for First-Line HER2-Positive Gastroesophageal Adenocarcinoma

The U.S. Food and Drug Administration has approved two Ziihera (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA). This includes Ziihera with and without tislelizumab plus chemotherapy, offering new options for patients with this aggressive cancer. The approval is supported by results from the Phase 3 HERIZON-GEA-01 trial, which demonstrated statistically significant and clinically meaningful improvements in progression-free survival.