Roche’s Companion Assay for Ovarian Cancer Drug Approved

The FDA has approved Roche’s Ventana FOLR1 assay as the first companion diagnostic test to identify patients eligible for treatment with ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) also recently FDA approved.

Both Roche’s assay and the Elahere treatment are for adult patients with folate receptor alpha positive, platinum-resistant ovarian cancer. The assay tests for a predictive biomarker expressed in about 90 percent of patients likely to benefit from the therapy.

The approval was based on a clinical trial in which about 35 percent of the 106 enrolled ovarian cancer patients were positive for the marker, as determined by the assay.