25 April 2025 - Jazz Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bi-specific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+)† biliary tract cancer previously treated with at least one prior line of systemic therapy.

The CHMP recommendation is based on data from the Phase 2b HERIZON-BTC-01 trial, which evaluated zanidatamab in previously treated, inoperable, and advanced or metastatic HER2 positive biliary tract cancer.

Read Jazz Pharmaceuticals press release