Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that HER2-positive status confers therapeutic sensitivity to Zanidatamab in patients with Intracholecystic Papillary Neoplasm.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.