Mirvetuximab soravtansine

Mirvetuximab soravtansine (Elahere, AbbVie Deutschland GmbH & Co. KG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: FRα (1).
Approved indications of Mirvetuximab soravtansine
Biomarker requirementRegimenSettingConditions
Ovarian cancer1
FRα FRα-positive
Monotherapy
2L
High-grade serous only; After 1 to 3 prior systemic treatment regimens; Platinum-resistant
Full text of section 4.1 (therapeutic indications)

ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens (see section 4.2).

Label history

2 changes to the Elahere label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes