Roche receives FDA approval for PATHWAY HER2 (4B5) test
The PATHWAY HER2 (4B5) test helps identify patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA
2 Dec 2024
Roche has received U.S. Food and Drug Administration (FDA) approval of a label expansion into biliary tract cancer (BTC) for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test. This test is now the first and only FDA-approved companion diagnostic to aid in the assessment of HER2-positive status to identify BTC patients who are 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 therapy1. ZIIHERA is the first FDA-approved treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.
The PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody delivers timely, clear and reliable results, enabling therapeutic decisions that can lead to better outcomes for patients. Already indicated as an aid to identify breast cancer patients eligible for HER2-targeted treatment with Herceptin®, KADCYLA® or ENHERTU®2, the test is used in combination with the fully automated VENTANA BenchMark slide staining instrument.
The introduction of the new indication for BTC represents a significant expansion of the test’s clinical utility. The assay forms an important part of Roche’s gastrointestinal cancer solutions portfolio, which is aimed at driving diagnostic certainty for life-changing decisions in cancer care.
The assay standardizes all immunohistochemistry (IHC) processes from baking through staining, and reduces the possibility of human error3. It also minimizes inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The Roche HER2 (4B5) clone achieves consistently high-proficiency assessment scores compared to other clones4 and demonstrates high concordance with HER2 FISH5,6, empowering laboratories to employ the most widely adopted and reliable HER2 IHC primary antibody.
References
1. Yoon, J., Oh, DY. Nat Rev Clin Oncol 21, 675–700 (2024).
2. PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, US Package Insert (D197603 Rev 1). 2024.
3. VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx Package Insert, 2024.
4. https://www.nordiqc.org/epitope.php
5. Mayr D., et al. Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest™ (Dako) for manual testing and Her-2/neuTest 4B5 (VENTANA) for VENTANA BenchMark automatic staining system with correlation to results of BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH). Virchows Archiv. 2009; 454(3):241–248.
6. Brügmann A., Lelkaitis G., Nielsen S., et al. Testing HER2 in breast cancer: a comparative study on BRISH, FISH, and IHC. Appl Immunohistochem Mol Morphol. 2011;19(3):203-211.
Want the latest science news straight to your inbox? Become a SelectScience member for free today>>