FDA Approves Zanidatamab-hrii as First-Line Therapy for HER2-Positive Gastroesophageal Cancers

The U.S. Food and Drug Administration (FDA) has approved the HER2-directed bispecific antibody zanidatamab-hrii (Ziihera) as a first-line treatment for adults with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This approval is based on the global Phase 3 HERIZON-GEA-01 trial, which demonstrated statistically significant improvements in progression-free survival and overall survival when combined with chemotherapy and the PD-1 inhibitor tislelizumab-jsgr.