Jazz Pharmaceuticals receives CHMP positive opinion for zanidatamab

Jazz Pharmaceuticals (JAZZ) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive 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 BTC