FDA Gives Nod to Mirvetuximab Soravtansine

The FDA has granted accelerated approval to mirvetuximab soravtansine to treat patients with folate receptor alpha (FRα)–positive, platinum-resistant epithelial ovarian, primary peritoneal, and fallopian tube cancers. The FDA also approved the VENTANA FOLR1 (FOLR-2.1) RxDx Assay companion diagnostic device, which detects the FRα protein and could determine which patients will likely respond to the antibody–drug conjugate.