zanidatamab

Zanidatamab is a humanized bispecific monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2). It binds to two distinct extracellular domains of HER2—the juxtamembrane domain and the dimerization domain—thereby blocking HER2 dimerization, promoting receptor degradation, and inhibiting downstream signaling pathways involved in cell proliferation and survival. This dual binding also enhances immune-mediated killing of cancer cells. Zanidatamab is approved for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (including cholangiocarcinoma and gallbladder cancer) as detected by an FDA-approved test. The drug is administered intravenously and was granted accelerated approval by the FDA in November 2024. It is considered first-in-class for this indication[1][3][5][6].

Brand names

Ziihera

Other names

zanidatamab-hrii