Roche (RHHBY) said Monday that the U.S. Food and Drug Administration approved 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 therapy developed by ImmunoGen,approved under FDA's Accelerated 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 percent 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.
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