FDA Approves Ziihera for Advanced HER2-Positive Gastroesophageal Cancer

The U.S. FDA has approved two Ziihera (zanidatamab-hrii)-containing regimens for first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma. This establishes a new standard of care as the first bispecific HER2-targeted antibody combined with a PD-1 inhibitor and chemotherapy for all HER2+ advanced GEA patients. The HERIZON-GEA-01 trial showed a median overall survival of 26.4 months.