FDA grants accelerated approval to Jazz Pharmaceuticals’ Ziihera

The Food and Drug Administration granted accelerated approval to zanidatamab-hrii, or Ziihera from Jazz Pharmaceuticals (JAZZ), Inc., a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. The FDA also approved VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody, from Ventana Medical Systems, Roche Diagnostics (RHHBY), as a companion diagnostic device to aid in identifying patients with BTC who may be eligible for treatment with Ziihera.