Swiss drug major Roche Group (RHHBY) announced Monday that it has received CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, which identifies ovarian cancer patients eligible for targeted treatment with ELAHERE (mirvetuximab soravtansine).
This is the first immunohistochemistry or IHC companion diagnostic test to be made widely available in Europe to help identify epithelial ovarian cancer or EOC patients who may be eligible for targeted treatment with ELAHERE.
Ovarian cancer, one of the deadliest gynaecological cancers worldwide, is the eighth overall cause for cancer death in women worldwide, representing 4.7% of all cancer deaths in women. In 2022, 46,232 women in Europe and 209,596 women worldwide died from ovarian cancer.
ELAHERE is a first-in-class antibody-drug conjugate or ADC therapy developed by AbbVie to treat FR?-positive platinum-resistant ovarian cancer.
Roche's VENTANA RxDx Assay is a qualitative immunohistochemical assay using mouse monoclonal anti-FOLR1 clone FOLR1-2.1 intended for use in the assessment of folate receptor alpha (FR?) in formalin-fixed, paraffin-embedded epithelial ovarian cancer.
The latest approval is based on the results from the SORAYA6 and MIRASOL7 clinical studies, which enrolled platinum-resistant epithelial ovarian cancer patients who were FR?-positive by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.
Earlier this year, the VENTANA FOLR1 (FOLR1-2.1) test had received pre-authorisation in Germany and Austria, allowing clinicians and patients in those countries to access the test ahead of the CE Mark certification.
Jill German, Head of Pathology Lab at Roche Diagnostics, said, "This certification will allow us to extend the reach of our innovative diagnostic solutions. The early exemption approval in Germany and Austria highlighted the urgent need for this test. Now, clinicians across Europe can access a critical tool to quickly identify ovarian cancer patients who may be eligible for targeted therapy. By enabling more precise and personalised treatment decisions, we hope this may help improve outcomes for the many women in Europe facing this devastating disease."
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