Jazz Pharmaceuticals Receives Conditional EU Approval For Ziihera To Treat HER2-Positive Biliary Tract Cancer Based On Phase 2b Trial

– Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial –

DUBLIN, July 1, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the European Commission (EC) has granted conditional marketing authorization1 for Ziihera® (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+)† biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.2

BTCs, which include gallbladder cancer (GBC) and cholangiocarcinoma (CCA), are a rare and aggressive group of cancers,3 with most cases diagnosed at an advanced stage4 when curative surgery is no longer an option.5,6,7 Globally, approximately 26% of patients with BTC are HER2-positive,8 a biomarker associated with poorer outcomes compared to HER2-negative disease.9

Ziihera is the first HER2-targeted therapy given conditional authorization for HER2-positive BTC in the European Union (EU). Continued approval for this indication is contingent upon verification and description of clinical benefit in the ongoing Phase 3 HERIZON-BTC-302 trial, which is evaluating zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.10