Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Zanidatamab in patients with Intraductal Papillary Neoplasm of the Bile Duct.
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.