Roche has received FDA approval for the PATHWAY HER2 (4B5) test as a companion diagnostic to identify patients with previously-treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii). This approval marks a significant advancement in personalized medicine for BTC, a cancer with limited treatment options and poor prognosis.
Addressing Unmet Needs in Biliary Tract Cancer
Biliary tract cancer accounts for approximately 3% of all gastrointestinal cancers in the US. The prognosis for BTC patients is generally poor due to the lack of early detection tools, challenging anatomical access for treatment, and aggressive tumor biology. Most cases are diagnosed at an advanced stage, leading to a five-year overall survival rate of only 19% for localized disease and 3% for cancer that has spread to other areas.
“This test is a step forward in furthering access to personalised medicine,” said Jill German, Head of Pathology Lab at Roche Diagnostics. “The prognosis for patients diagnosed with BTC is poor, as very few treatment options exist. Now, these patients have access to the first standardised test that could make them eligible for targeted therapy, potentially improving clinical outcomes.”
The Role of HER2 in Biliary Tract Cancer
HER2, a receptor protein expressed in various cancers, serves as a predictive biomarker for HER2-targeted therapy response. Until now, no approved and validated HER2 test existed to identify eligible BTC patients. The PATHWAY HER2 (4B5) test fills this critical gap, enabling clinicians to determine which patients are most likely to benefit from ZIIHERA, the first FDA-approved treatment for adults with previously-treated, unresectable, or metastatic HER2-positive biliary tract cancer.
About the PATHWAY HER2 (4B5) Test
The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is designed to deliver timely, clear, and reliable results. It standardizes all immunohistochemistry (IHC) processes, reducing the possibility of human error and minimizing variability found in manual IHC methods. The Roche HER2 (4B5) clone has demonstrated consistently high proficiency assessment scores and high concordance with HER2 FISH.
Previously, the PATHWAY HER2 (4B5) test was indicated as an aid to identify breast cancer patients eligible for HER2-targeted treatments like Herceptin, KADCYLA, or ENHERTU. The expansion of its clinical utility to include BTC represents a significant advancement in Roche's comprehensive gastrointestinal cancer solutions portfolio.
