Roche announced 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 Inc., approved under FDA'sAccelerated Approval program for the treatment of FR?-positive platinum-resistant ovarian cancer. Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FR?), is expressed at some level in approximately 90% of ovarian carcinomas and serves as a predictive biomarker for FOLR1-targeted therapy for EOC patients.1,2 The new test informs clinicians about the likelihood of potential patient benefit from FOLR1 therapy,3,4 advancing Roche'scommitment to personalised healthcare through innovative solutions that help fit the treatment to the individual.

The approval is based on the results of the SORAYA clinical study.4 In the study, approximately 35% of ovarian cancer patients expressed high levels of FRa (defined as = 75% tumour cells staining with 2+/3+ intensity) and were considered FRa-positive by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Of the FRa-positive patients, about 32% 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 in order to advance personalised healthcare and deliver novel, high medical value solutions that improve patients' lives.