Roche bags US FDA approval for diagnostic test to aid in identifying epithelial ovarian cancer

ENTANA FOLR1 (FOLR1-2.1) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test

Roche announced the US Food and Drug Administration (FDA) approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying epithelial ovarian cancer (EOC) patients who are eligible for targeted treatment with ELAHERE (mirvetuximab soravtansine-gynx). ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by ImmunoGen, approved under the FDA’s Accelerated Approval programme for the treatment of FRɑ-positive platinum-resistant ovarian cancer.

Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRɑ), is expressed at some level in approximately 90 per cent of ovarian carcinomas and serves as a predictive biomarker for FOLR1-targeted therapy for EOC patients. The new test informs clinicians about the likelihood of potential patient benefit from FOLR1 therapy, advancing Roche’s commitment to personalised healthcare through innovative solutions that help fit the treatment to the individual.

“We’re proud to expand our women’s health and oncology portfolios through the addition of the first companion diagnostic IHC test for ovarian cancer,” said Jill German, Head of Pathology Lab at Roche Diagnostics. “This test will enable clinicians to make more informed treatment decisions for patients with ovarian cancer by quickly determining whether they qualify for ELAHERE therapy, potentially improving their outcomes.”

The approval is based on the results of the SORAYA clinical study. In the study, approximately 35 per cent of ovarian cancer patients expressed high levels of FRα (defined as ≥ 75 per cent tumour cell staining with 2+/3+ intensity) and were considered FRα-positive by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Of the FRα-positive patients, about 32 per cent demonstrated a partial or complete response to ELAHERE therapy.

The launch of Roche’s first companion test for ovarian cancer highlights the company’s commitment, as the world’s leading provider of in vitro diagnostics, to continued innovation and evolution of its products to advance personalised healthcare and deliver novel, high medical value solutions that improve patients’ lives.