SWITZERLAND – Roche has received FDA approval for its PATHWAY HER2 (4B5) test, making it the first companion diagnostic tool designed to identify patients with biliary tract cancer (BTC) who are eligible for HER2-targeted therapy using ZIIHERA.
This approval marks a significant breakthrough for BTC patients, who have few treatment options due to the typically late-stage diagnosis of this aggressive cancer.
BTC is a rare and difficult-to-treat cancer that accounts for only 3% of gastrointestinal cancers in the U.S. It has a particularly poor prognosis, with a five-year survival rate of just 19% for localized disease and only 3% for metastatic cases.
Most BTC patients are diagnosed at an advanced stage, leaving limited options for treatment.
The PATHWAY HER2 (4B5) test addresses this gap by offering a standardized method to identify those who may benefit from HER2-targeted treatments, specifically ZIIHERA, which is the first FDA-approved therapy for HER2-positive, unresectable or metastatic BTC.
“The prognosis for patients diagnosed with BTC is poor, as very few treatment options exist. Now, these patients have access to the first standardized test that could make them eligible for targeted therapy, potentially improving clinical outcomes,” said Jill German, Head of Pathology Lab at Roche Diagnostics.
HER2 is a protein that can be found in several cancers and serves as a predictive biomarker for determining which patients may respond to HER2-targeted therapies.
This approval not only expands the clinical utility of Roche’s existing PATHWAY HER2 test, previously used for breast cancer, but it also opens a new market for BTC diagnostics.
While BTC represents a small portion of gastrointestinal cancers, the test’s approval provides a critical tool for doctors to make more informed, targeted treatment decisions.
However, the test is specific to HER2-positive BTC patients, limiting its application to a subset of the BTC population.
The PATHWAY HER2 (4B5) test works in conjunction with Roche’s fully automated VENTANA BenchMark slide staining system, ensuring precise, reliable results that reduce human error and variability.
It’s now part of Roche’s broader gastrointestinal cancer portfolio, supporting accurate diagnoses and treatment plans that can make a life-changing difference for patients.
This approval enhances the potential for personalized medicine in BTC and strengthens Roche’s competitive position in the oncology diagnostic market, offering a promising new path forward for patients battling this difficult cancer.
