# Tisotumab vedotin

Tisotumab vedotin (Tivdak, Genmab A/S) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Cervical cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | Disease progression on or after systemic therapy |

## Products

### Tivdak

- Company: Genmab A/S
- Target: TF-directed antibody-drug conjugate (MMAE)
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX23
- EU approval: 28 Mar 2025
- Label revised: 5 Jun 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tivdak-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tivdak-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tivdak

Mechanism (SmPC section 5.1): Binds tissue factor (TF) on tumour cells and is internalised, then releases MMAE, which disrupts microtubules and causes cell-cycle arrest and apoptotic cell death.

## Label wording

- **Tisotumab vedotin** (Tivdak), Cervical cancer, 2nd line, advanced: “Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tivdak-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/tisotumab-vedotin