Roche announces FDA approval of label expansion into biliary tract cancer

Roche (RHHBY) announced the FDA approval of a label expansion into biliary tract cancer, or BTC, for the Pathway anti-HER2/neu 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’ (JAZZ) Zihera.