# Enfortumab vedotin

Enfortumab vedotin (Padcev, Astellas Pharma Europe B.V.) has 4 EU-approved indications in 1 tumour type.

## Approved indications

### Urothelial carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + pembrolizumab | Neoadjuvant, early | Muscle-invasive only; Then adjuvant enfortumab vedotin + pembrolizumab after surgery |
| None | + pembrolizumab | Adjuvant, early | Muscle-invasive only; After neoadjuvant enfortumab vedotin + pembrolizumab and radical cystectomy |
| None | + pembrolizumab | 1st line, advanced | Eligible for platinum-containing chemotherapy |
| None | Monotherapy | 2nd line, advanced | Previously received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor |

## Products

### Padcev

- Company: Astellas Pharma Europe B.V.
- Target: Nectin-4-directed antibody-drug conjugate
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX13
- EU approval: 13 Apr 2022
- Label revised: 16 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/padcev-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/padcev

Mechanism (SmPC section 5.1): Binds Nectin-4 on cancer cells, internalises, and releases MMAE to disrupt microtubules, causing cell cycle arrest and apoptosis.

## Label wording

- **Enfortumab vedotin** (Padcev), Urothelial carcinoma, neoadjuvant, early: “Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf)
- **Enfortumab vedotin** (Padcev), Urothelial carcinoma, adjuvant, early: “Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf)
- **Enfortumab vedotin** (Padcev), Urothelial carcinoma, 1st line, advanced: “Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf)
- **Enfortumab vedotin** (Padcev), Urothelial carcinoma, 2nd line, advanced: “Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/padcev-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/enfortumab-vedotin