Roche has received expanded approval from the US Food and Drug Administration (FDA) for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test as a companion diagnostic.
PATHWAY test is now approved to identify patients with biliary tract cancer (BTC) eligible for treatment with Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii).
Roche said the label expansion makes it the first FDA-approved companion diagnostic for assessing HER2-positive status in BTC patients.
HER2 is a receptor protein found in various cancers. It acts as a predictive biomarker to determine if a patient will respond to HER2-targeted therapies.
Ziihera is intended for the treatment of adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) BTC. It recently secured the FDA accelerated approval based on the data from the HERIZON-BTC-01 trial.
Roche Diagnostics pathology lab head Jill German said: “This test is a step forward in furthering access to personalised medicine.
“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.”
According to Roche, the PATHWAY test provides timely, clear, and reliable results, supporting therapeutic decisions for better patient outcomes.
The test, initially approved to help identify breast cancer patients eligible for HER2-targeted treatments like Herceptin, Kadcyla, and Enhertu, is now also indicated for BTC.
It works in combination with the fully automated VENTANA BenchMark slide staining instrument.
This new BTC indication significantly expands the test’s clinical use, strengthening Roche’s gastrointestinal cancer solutions portfolio and enhancing diagnostic certainty for critical cancer care decisions.
The latest approval comes after Roche secured CE mark approval for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as a companion diagnostic to identify ovarian cancer patients eligible for Elahere.
Last month, the pharma company received the FDA approval for VENTANA CLDN18 (43-14A) RxDx Assay as companion diagnostic to identify patients eligible for treatment with Astellas’ targeted therapy Vyloy (zolbetuximab).
In September this year, Roche Diagnostics partnered with Singapore-based health technology company Respiree to boost patient monitoring across the Asia Pacific (APAC) region.
