Elahere (mirvetuximab soravtansine-gynx) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
ELAHERE is a folate receptor alpha (FRα)-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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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