Posted by Michael Wonder on 29 Nov 2024
FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2 positive biliary tract cancer
20 November 2024 - Today, 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 3+) biliary tract cancer, as detected by an FDA approved test.
Today, the FDA also approved VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems/Roche Diagnostics) as a companion diagnostic device to aid in identifying patients with biliary tract cancer who may be eligible for treatment with Ziihera.
