Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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

Contributions

Date	Contributor	Description
2025-09-08	Van Allen lab	On 2025-07-03, the EMA approved Ziihera (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.
2025-06-27	European Medicines Agency	Indication received approval from the European Commission.