Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Zanidatamab in patients with Cholangiocarcinoma.

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.