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FDA Approves Expanded Use of Roche’s PATHWAY® HER2 Test for Biliary Tract Cancer

NextEdge Admin

26 Nov 2024

2 min 29 sec

Roche announced FDA approval of a label expansion for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to include biliary tract cancer (BTC). This test is now the first FDA-approved companion diagnostic to identify HER2-positive BTC patients eligible for Jazz Pharmaceuticals’ ZIIHERA® (zanidatamab-hrii), the first HER2-targeted therapy approved for previously treated, unresectable, or metastatic HER2-positive BTC.

HER2, a receptor protein and predictive biomarker, plays a critical role in guiding targeted therapy. Before this approval, no validated HER2 test existed for BTC patients. “This milestone brings hope to BTC patients who now have access to a standardized test that could enable targeted therapy, potentially improving outcomes,” said Jill German, Head of Pathology Lab at Roche Diagnostics.

BTC represents 3% of gastrointestinal cancers in the U.S., with a poor prognosis due to late-stage diagnoses, aggressive tumor biology, and limited treatment options. The five-year survival rate is 19% for localized cases and just 3% for advanced disease. The PATHWAY HER2 (4B5) test is a critical advancement in addressing this unmet need.

Already used to identify HER2-positive breast cancer patients eligible for therapies like Herceptin®, KADCYLA®, and ENHERTU®, the PATHWAY HER2 (4B5) test integrates seamlessly with Roche’s automated VENTANA BenchMark staining platform, ensuring standardized, reliable results. The assay minimizes variability and reduces human error, delivering high concordance with HER2 FISH testing and achieving consistently high-proficiency scores.

This expanded indication solidifies the test's role in Roche’s gastrointestinal cancer solutions portfolio, furthering personalized medicine and enhancing diagnostic certainty for life-changing cancer care decisions.