Biopharmaceutical company Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced on Friday that it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending conditional marketing authorisation of zanidatamab as monotherapy for adults with unresectable or metastatic HER2-positive biliary tract cancer previously treated with systemic therapy.

The recommendation is based on results from the Phase 2b HERIZON-BTC-01 trial, which demonstrated clinical activity in patients with advanced disease. Zanidatamab, a bispecific antibody targeting HER2, has shown tumour growth inhibition and cell death through multiple immune-mediated mechanisms.

Biliary tract cancers represent less than 1% of all cancers and are typically diagnosed at an advanced stage. HER2-positive subtypes account for approximately 26% of BTC cases and are associated with poorer prognosis, with no HER2-targeted treatments currently approved in the European Union.

The European Commission is expected to make a final decision following the CHMP opinion. Zanidatamab is being developed under licence from Zymeworks by Jazz and BeiGene Ltd, with Jazz holding commercial rights in key global markets outside parts of the Asia-Pacific region.

In November 2024, the US Food and Drug Administration granted accelerated approval for zanidatamab (Ziihera) in this indication. The approval remains contingent on confirmatory data from the ongoing Phase 3 HERIZON-BTC-302 trial.

Zanidatamab has received multiple regulatory designations, including Breakthrough Therapy, Fast Track and Orphan Drug status in the US and EU for various HER2-expressing cancers.