The FDA granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC [immunohistochemistry] 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
The FDA also approved VENTANA PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems/Roche Diagnostics) as a companion diagnostic device to aid in identifying patients with BTC
NOVEMBER 25, 2024