Roche has received the CE mark for expanded indications of its VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx test, under the European Union’s (EU) in vitro diagnostic regulation (IVDR).
VENTANA HER2 (4B5) was already approved in Europe to identify metastatic breast cancer patients with low human epidermal growth factor receptor 2 (HER2) expression.
The test determines patients eligible for treatment with Enhertu (trastuzumab deruxtecan), jointly developed and marketed by Daiichi Sankyo and AstraZeneca.
The expanded approval allows the test to identify patients with HER2-positive biliary tract cancer, who may be eligible for treatment with Ziihera (zanidatamab-hrii).
Ziihera is a bispecific antibody that targets HER2 in adults with HER2-positive biliary tract cancer (BTC), developed by Jazz Pharmaceuticals and BeiGene.
The VENTANA HER2 (4B5) test has also been approved by the EU for identifying a new patient population designated as HER2-ultralow, who have very low HER2 expression.
The HER2-ultralow category is estimated to comprise 20-25% of hormone receptor (HR)-positive, HER2-negative breast cancer patients.
By identifying the patients in the HER2-ultralow category, the VENTANA HER2 (4B5) test is expected to expand the eligibility criteria for Enhertu.
The patients with HER2-low and HER2-ultralow metastatic breast cancer may now use Enhertu, based on positive results from the DESTINY-Breast06 trial.
Roche said that its VENTANA HER2 (4B5) assay provides timely, clear and reliable diagnostic results, enhancing therapeutic decision-making.
Used with the VENTANA BenchMark slide staining instrument, the assay standardises all immunohistochemistry (IHC) processes, reducing human error and variability.
Also, the test maintains high assessment scores and concordance with HER2 FISH (fluorescence in situ hybridisation) test, said Roche.
Roche Diagnostics pathology lab head Jill German said: “This is about creating new options for patients facing some of the toughest cancers.
“Our understanding of HER2 is rapidly evolving, and this expanded approval ensures our diagnostics are leading the way.
“We’re enabling clinicians to unlock personalised, life-altering treatments for patients who urgently need them.”
