Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FOLR1 positive status confers therapeutic sensitivity to Mirvetuximab soravtansine in patients with Ovarian Epithelial Tumor.
The U.S. Food and Drug Administration granted approval to mirvetuximab soravtansine-gynx for the treatment of adult patients with folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The package insert states to select patients for therapy based on an FDA-approved test and, furthermore, that folate receptor-alpha tumor positive is defined as the presence of folate receptor-alpha tumor expression.
This statement is based on a regulatory approval from the Food and Drug Administration:
ELAHERE is a folate receptor alpha (FRĪ±)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FR-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.