Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer

Roche has announced the U.S. FDA approval of a label expansion into biliary tract cancer (BTC) for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test. This test is now the first and only FDA-approved companion diagnostic to aid in the assessment of HER2-positive status to identify BTC patients who are eligible for treatment with Jazz Pharmaceuticals' ZIIHERA (zanidatamab-hrii).

HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.1 No approved and validated HER2 test existed to identify eligible BTC patients until the approval of this expanded label for the PATHWAY HER2 (4B5) test.

ZIIHERA is the first FDA-approved treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.