Jazz Pharmaceuticals Receives Approval for Ziihera® for Advanced HER2-Positive Biliary Tract Cancer
Wednesday, July 02, 2025
Jazz Pharmaceuticals has received conditional marketing authorisation from the European Commission (EC) for Ziihera® (zanidatamab), a bispecific antibody targeting HER2, for the treatment of adults with unresectable locally advanced or metastatic HER2-positive biliary tract cancer (BTC) who have received at least one previous line of systemic therapy.
Biliary tract cancers, which include gallbladder cancer and cholangiocarcinoma, are rare and aggressive, often diagnosed at an advanced stage when surgery is no longer possible. Approximately 26% of BTC cases are HER2-positive, a subtype associated with poorer clinical outcomes compared to HER2-negative disease.
BTC remains a challenging condition with limited treatment options, especially after first-line therapy. HER2 testing is becoming increasingly important to help guide targeted treatment decisions for affected patients.
Ziihera is the first HER2-targeted therapy granted conditional approval in the EU for this patient group. Continued authorisation is dependent on results from the ongoing Phase 3 HERIZON-BTC-302 trial, which is evaluating zanidatamab in combination with standard therapy in the first-line setting.
Ziihera is a bispecific antibody that targets two domains of the HER2 receptor, leading to receptor internalisation and reduction on the cell surface. It also activates immune responses that contribute to tumour cell death.
The approval is based on data from the Phase 2b HERIZON-BTC-01 study involving 87 previously treated patients with HER2-positive BTC.
The recommended dose of Ziihera is 20 mg/kg, administered intravenously every two weeks until disease progression or unacceptable toxicity.
The most common adverse reactions included diarrhoea, infusion-related reactions, abdominal pain, anaemia, and fatigue. Serious adverse reactions occurred in 16.1% of participants.
The EC approval covers all EU member states as well as Iceland, Norway, and Liechtenstein.
The product has received multiple regulatory designations, including Breakthrough Therapy and Orphan Drug status in the US and EU for various cancer indications.
Jazz Pharmaceuticals holds the commercialisation rights for zanidatamab in the US, Europe, Japan, and most global markets, while BeOne Medicines and Zymeworks retain rights in select Asia-Pacific regions.
Source: prnewswire.com
