Ziihera (zanidatamab-hrii) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Astellas Pharma US, Inc. Ziihera (zanidatamab-hrii) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761416Orig1s000Lbl.pdf. Revised November 2024. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

ZIHERA is a bispecific HER2-directed antibody indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	HER2-positive	Intraductal Papillary Neoplasm of the Bile Duct	Zanidatamab
FDA (1)	HER2-positive	Intracholecystic Papillary Neoplasm	Zanidatamab
FDA (1)	HER2-positive	Cholangiocarcinoma	Zanidatamab