• The FDA has granted accelerated approval to zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer.
• Approval was based on the HERIZON-BTC-01 trial, which demonstrated a 52% objective response rate and a median duration of response of 14.9 months.
• Zanidatamab, a bispecific HER2-directed antibody, is administered intravenously every two weeks at a dose of 20 mg/kg until disease progression or unacceptable toxicity.
• The FDA also approved the Ventana PATHWAY anti-HER-2/neu antibody as a companion diagnostic to identify patients eligible for zanidatamab treatment.