Therapeutic Response

HER2-positive status confers therapeutic sensitivity to Zanidatamab in patients with Intraductal Papillary Neoplasm of the Bile Duct.

Statements

Source and description
Ziihera (zanidatamab-hrii) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted accelerated approval to zanitdatamab for the treatment of adult patients with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. The package insert states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Ziihera (zanidatamab) [product information]. EMA. The European Medicines Agency (EMA) has authorized zanidatamab for the treatment of adult patients with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.