NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending conditional marketing authorization for Jazz Pharmaceuticals' Ziihera (zanidatamab) as a second-line treatment for advanced HER2-positive biliary tract cancer.
Ziihera is a bispecific HER2-directed antibody originally developed by Zymeworks and being advanced by Dublin-based Jazz and BeiGene under license agreements. The drug binds to HER2 receptors and, through cytotoxicity and phagocytosis mechanisms, is designed to kill tumor cells and prevent replication.
The CHMP is recommending that the European Commission approve Ziihera specifically for adults with unresectable, locally advanced or metastatic HER2-positive biliary tract cancer, who have received at least one prior systemic therapy. Patients must overexpress HER2 with an immunohistochemistry test score of 3+.
The committee made its recommendation based on data from the Phase IIb HERIZON-BTC-01 trial, which demonstrated patients on Ziihera had a median overall survival of 15.5 months. Historically, advanced biliary tract cancer patients who have progressed on first-line systemic treatment have a poor prognosis and live an average of six months to nine months on subsequent chemotherapy.
"This positive CHMP opinion is a welcome step for physicians and patients in Europe who face a critical unmet need in HER2-positive biliary tract cancers, a rare and aggressive group of cancers with poor prognosis and limited treatment options," said Robert Iannone, executive VP, global head of research and development, and chief medical officer at Jazz.
Biliary tract cancers, which include gallbladder cancer and cholangiocarcinoma, are often diagnosed in later stages when surgery is ineffective. Existing second-line treatments are limited to chemotherapy. Around a quarter of biliary tract cancer patients overexpress HER2, but there are no HER2-targeted therapies approved for patients in the European Union in this setting.
The US Food and Drug Administration granted accelerated approval to Ziihera for this same indication in November 2024. Subsequently, the FDA approved Roche's Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test for identifying patients with HER2-positive cancer who are eligible for the drug.
The EC will now review CHMP's recommendation and decide whether to approve Ziihera in this setting.