Roche announced it has received CE IVDR approval for two label expansions of its VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx assay*. HER2, a receptor protein expressed in several cancers, is a predictive biomarker used to identify patients who may benefit from HER2-targeted therapies.
The VENTANA HER2 (4B5) assay is now the first and only companion diagnostic approved to detect HER2-ultralow expression in patients with HR-positive metastatic breast cancer. These patients may be eligible for treatment with ENHERTU® (trastuzumab deruxtecan), an engineered HER2-directed antibody drug conjugate (ADC) developed by Daiichi Sankyo and AstraZeneca.
The test was used in the DESTINY-Breast06 trial, which showed that ENHERTU significantly improved progression-free survival compared with standard chemotherapy in patients with HER2-low and HER2-ultralow breast cancer.
The test is also now the first and only companion diagnostic approved to determine HER2-positive biliary tract cancer (BTC) patients with an IHC score of 3+, who may be eligible for ZIIHERA® (zanidatamab-hrii) from Jazz Pharmaceuticals.
BTC is often diagnosed at late stages, with few available treatment options and poor prognosis. The expanded approval offers a critical diagnostic tool to address this unmet need.
"This is about creating new options for patients facing some of the toughest cancers," said Jill German, Head of Pathology Lab at Roche Diagnostics. "Our understanding of HER2 is rapidly evolving, and this expanded approval ensures our diagnostics are leading the way. We're enabling clinicians to unlock personalized, life-altering treatments for patients who urgently need them."
In Europe, more than 564,000 people are diagnosed with breast cancer each year, with 145,000 deaths estimated annually. Traditional HER2 interpretation has shifted from binary positive/negative categories to include HER2-low and now HER2-ultralow, which may represent up to 25% of HR-positive, HER2-negative breast cancer cases.
This evolution highlights the growing role of advanced diagnostics in expanding access to targeted therapies for patients with difficult-to-treat cancers.