More than a week ahead of its priority PDUFA date, the U.S. FDA has greenlit the first dual HER2-targeted bispecific antibody specifically for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The approval went to Jazz Pharmaceuticals plc for Ziihera (zanidatamab), an injection given to adults every two weeks. The treatment was designed to have a more favorable profile than competitors, where drugs targeting HER2 such as Astrazeneca plc’s Enhertu (trastuzumab deruxtecan) and Roche Holding AG’s Herceptin (trastuzumab) are options, as well as checkpoint inhibitors such as Merck & Co Inc.’s Keytruda (pembrolizumab).