Regulatory approval

Published by the European Medicines Agency. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	FOLR1 positive	Ovarian Epithelial Tumor	Mirvetuximab soravtansine
EMA (1)	FOLR1 positive	High-Grade Serous Fallopian Tube Cancer	Mirvetuximab soravtansine
EMA (1)	FOLR1 positive	Peritoneal Serous Carcinoma	Mirvetuximab soravtansine

Contributions

Date	Contributor	Description
2025-09-08	Van Allen lab	On 2024-12-11, the EMA provided approval to Elahere (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.
2024-11-14	European Medicines Agency	Indication received approval from the European Commission.