The US FDA has approved zanidatamab for treating adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC). Zanidatamab is a bispecific HER2-directed antibody that inhibits tumor growth and facilitates cell death. Clinical evidence In a clinical trial conducted on 62 patients with HER2-positive BTC, zanidatamab achieved an objective response rate of 52% with a duration of response lasting 14.9 months. Dosage and administration Available as lyophilized powder Intravenous infusion (20 mg/kg) once every two weeks Warnings and precautions Left ventricular dysfunction Infusion-related reactions Diarrhea Adverse reactions – Abdominal pain, fatigue, and diarrhea Did you find this FDA Alert interesting?
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