Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA

The PATHWAY HER2 (4B5) test helps to identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA. There are currently very few options for BTC patients as most cases are at an advanced stage at the time of diagnosis. This approval represents a new indication for Roche's existing PATHWAY HER2 (4B5) test and expands its clinical utility by broadening the scope of patients who are eligible for HER2-targeted thera ...