Jazz Pharma Secures CHMP Support for Zanidatamab for Treatment of Advanced HER2-Positive Biliary Tract Cancer

Benzinga·04/25/2025 15:30:42

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DUBLIN, April 25, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational 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.

The CHMP's recommendation will now be reviewed by the European Commission which has the authority to approve medicines in all EU Member States, Iceland, Norway, and Liechtenstein, and is expected to make a final decision.

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