Jazz Pharmaceuticals plc (JAZZ) announced Tuesday that the European Commission (EC) has granted conditional marketing authorization 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.
BTCs, which include gallbladder cancer (GBC) and cholangiocarcinoma (CCA), are a rare and aggressive group of cancers, with most cases diagnosed at an advanced stage4 when curative surgery is no longer an option. 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.
The EC decision is based on data from the Phase 2b HERIZON-BTC-01 trial, which evaluated Ziihera in patients with previously treated, unresectable, locally advanced or metastatic HER2-positive BTC. This is the largest Phase 2b trial conducted to date specifically in this population.
The recommended dose of Ziihera is 20 mg/kg, administered as an intravenous infusion every two weeks until disease progression or unacceptable toxicity.
The European Commission authorization extends to all European Union Member States, as well as Iceland, Norway, and Liechtenstein.
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