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.

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Regulatory approvals

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

Indication Statements
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. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (1) FOLR1 positive Ovarian Epithelial Tumor Mirvetuximab soravtansine
FDA (1) FOLR1 positive High-Grade Serous Fallopian Tube Cancer Mirvetuximab soravtansine
FDA (1) FOLR1 positive Peritoneal Serous Carcinoma Mirvetuximab soravtansine