Roche Gets FDA Approval For First Companion Diagnostic For HER2 Treatment In Biliary Tract Cancer

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(RTTNews) - Roche (RHHBY) announced that the U.S. Food and Drug Administration has approved an expansion of the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test label to include biliary tract cancer (BTC). This test is now the first and only FDA-approved companion diagnostic to assess HER2-positive status and identify BTC patients 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. 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.

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