1 July 2025 - Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial.
Jazz Pharmaceuticals today announced that the European Commission has granted conditional marketing authorization for Ziihera (zanidatamab), a dual HER2 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.