December 2024—Roche announced FDA approval of a label expansion into biliary tract cancer for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, a companion diagnostic to aid in the assessment of HER2-positive status to identify patients with biliary tract cancer who are eligible for treatment with zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals). Ziihera is an FDA-approved treatment for adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. The Pathway HER2 (4B5) test is used in combination with the Ventana BenchMark slide staining instrument.
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