Ziihera (zanidatamab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Jazz Pharmaceuticals Ireland Limited. Ziihera (zanidatamab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/ziihera-epar-product-information_en.pdf.pdf. Revised July 2025. Accessed September 8, 2025.

Regulatory approvals

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

Indication	Statements
Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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