# 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

### Ovarian cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| FRα FRα-positive | Monotherapy | 2nd line | High-grade serous only; After 1 to 3 prior systemic treatment regimens; Platinum-resistant |

## Products

### Elahere

- Company: AbbVie Deutschland GmbH & Co. KG
- Target: FRα-directed antibody-drug conjugate
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX26
- EU approval: 14 Nov 2024
- Label revised: 23 Jan 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/elahere-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/elahere-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/elahere

Mechanism (SmPC section 5.1): Binds FRα on ovarian cancer cells and is internalised, releasing the microtubule inhibitor DM4, which disrupts microtubules and causes cell cycle arrest and apoptosis.

## Label wording

- **Mirvetuximab soravtansine** (Elahere), Ovarian cancer, 2nd line: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/elahere-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/mirvetuximab-soravtansine