Roche receives FDA approval for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as an IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE

Nov. 18, 2022
News from Roche.

Roche announced U.S. Food and Drug Administration (FDA) approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, an 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 an antibody-drug conjugate (ADC) therapy developed by ImmunoGen, Inc., approved under FDA’s Accelerated Approval program 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% 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. 

The approval is based on the results of the SORAYA clinical study. In the study, approximately 35% of ovarian cancer patients expressed high levels of FRα (defined as ≥ 75% viable tumor cells with membrane staining at moderate and/or strong intensity levels) and were considered FRα-positive by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Of the FRα-positive patients, about 32% demonstrated a partial or complete response to ELAHERE therapy. 

Roche release