Jazz Pharmaceuticals (JAZZ) said Friday it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for zanidatamab to treat adults with unresectable locally advanced or metastatic HER2-positive biliary tract cancer.
The recommendation for the conditional marketing authorization of the investigational monotherapy in the European Union is backed by data from a phase 2b trial of patients previously treated with systemic therapy, according to the biopharmaceutical company.
The European Commission is expected to make a final decision based on the Committee's recommendation, Jazz Pharmaceuticals said.
JAZZ shares were edging 0.6% higher in recent trading.
Price: 109.58, Change: +0.60, Percent Change: +0.55
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