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Roche Nabs FDA Approval for Ventana Test as CDx for Elahere

NEW YORK – Roche announced on Monday that its Ventana FOLR1 RxDx test has received approval from the US Food and Drug Administration as a companion diagnostic for ImmunoGen's Elahere (mirvetuximab soravtansine-gynx). 

The test detects the folate receptor 1 protein, which is over-expressed in most ovarian cancers, and is intended to identify patients with epithelial ovarian cancer who are eligible for treatment with Elahere. The qualitative immunohistochemical assay assesses folate receptor alpha in formalin-fixed, paraffin-embedded ovarian cancer tissue specimens and provides information about the likelihood of a patient's potential benefit from treatment, Roche said in a statement. 

The approval is based on the Soraya clinical study, in which 35 percent of ovarian cancer patients expressed high levels of folate receptor alpha and were considered positive by the Ventana test. Of those patients, approximately 32 percent demonstrated a partial or complete response to Elahere therapy, Roche said. 

The drug received accelerated approval from the FDA in conjunction with the Ventana test with an indication for patients who have received one to three prior systemic treatment regimens.