Regulatory approval
Published by the Food and Drug Administration.
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 is written in the approval document as:
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.
Citation
ImmunoGen, Inc. Elahere (mirvetuximab soravtansine-gynx) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761310Origs005lbl.pdf. Revised March 2024. Accessed October 30, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | FOLR1 positive | Ovarian Epithelial Tumor | Mirvetuximab soravtansine | |
| Sensitivity (+) | FOLR1 positive | High-Grade Serous Fallopian Tube Cancer | Mirvetuximab soravtansine | |
| Sensitivity (+) | FOLR1 positive | Peritoneal Serous Carcinoma | Mirvetuximab soravtansine |