Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized mirvetuximab soravtansine for the treatment of adult patients with with folate receptor-alpha (FDalpha) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

This is written in the approval document as:

ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FDalpha) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

Citation

AbbVie Deutschland GmbH & Co. KG. Elahere (mirvetuximab soravtansine) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/elahere-epar-product-information_en.pdf. Revised August 2025. Accessed September 8, 2025.

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