Roche has announced that the US Food and Drug Administration (FDA) has authorized an expansion of its label to include the use of the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test for biliary tract cancer (BTC). This test stands out as the exclusive FDA-approved companion diagnostic designed to evaluate HER2-positive status, thereby identifying BTC patients eligible for Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) treatment.
HER2, a receptor protein prevalent in several cancer types, acts as an essential predictive biomarker to assess if a patient can benefit from HER2-targeted therapies. Prior to this approval, no validated HER2 testing had been available specifically to determine BTC patient eligibility. The expanded label for the PATHWAY HER2 (4B5) test fills this significant void.
Jill German, Head of Roche Diagnostics Pathology Lab, expressed, “This diagnostic advancement marks a pivotal step toward broadening access to individualized medical treatments. Given the dismal outlook for those diagnosed with BTC, due to a limited treatment repertoire, this new testing tool offers a pathway to targeted therapy that might enhance clinical results for patients.”
Ziihera is acknowledged as the first FDA-sanctioned therapy for adults who have undergone former treatments for, but still struggle with, inoperable or metastatic HER2-positive (IHC 3+) biliary tract cancer.
In the United States, BTC comprises just 3% of all gastrointestinal cancers. The outlook for patients is bleak, largely because of inadequate early detection tools, the challenging physical location of the tumors, their aggressive nature, and the limited benefits offered by systemic treatments. Most BTC cases are diagnosed at advanced stages, with a mere 19% five-year survival rate for localized diseases and only 3% for those that have metastasized.
The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody yields transparent and dependable results, facilitating more informed therapeutic choices that could improve patient outcomes. Previously utilized to determine breast cancer patients’ eligibility for HER2-focused treatments such as Herceptin, Kadcyla, or Enhertu, the test works alongside the fully automated Ventana BenchMark slide staining instrument. The addition of BTC into its remit considerably broadens the diagnostic’s clinical applications. This assay is an integral component of Roche’s extensive suite of gastrointestinal cancer solutions, designed to enhance diagnostic accuracy for critical cancer care decisions.
The diagnostic procedure standardizes all steps in the immunohistochemistry (IHC) workflow, from baking to staining, effectively reducing human errors. Additionally, it minimizes the variability inherent in processes like reagent dilution typically found in manual and semi-automated IHC methods. The Roche HER2 (4B5) clone consistently achieves great proficiency assessment scores relative to other clones and aligns well with HER2 FISH, thus enabling laboratories to use one of the most widely trusted HER2 IHC primary antibodies.
Since its foundation in 1896 in Basel, Switzerland, Roche has risen to become the leading biotechnology enterprise worldwide and a frontrunner in in-vitro diagnostics. Committed to scientific excellence, Roche continuously endeavors to discover and develop medicines and diagnostics to enhance and save the lives of individuals globally.