Jazz Pharmaceuticals: FDA accepts, grants Priority Review of BLA for zanidatamab

Jazz Pharmaceuticals announced that the U.S. FDA has accepted and granted Priority Review of the Biologics License Application for zanidatamab, the human epidermal growth factor receptor 2-targeted bispecific antibody, for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer. Under the Prescription Drug User Fee Act, FDA has set a target action date of November 29, 2024.