# Nadofaragene firadenovec

Nadofaragene firadenovec (Adstiladrin, Ferring Pharmaceuticals A/S) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Urothelial carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Early | Non-muscle-invasive only; BCG-unresponsive; carcinoma in situ (CIS) with or without papillary tumours |

## Products

### Adstiladrin

- Company: Ferring Pharmaceuticals A/S
- Target: IFNα2b-expressing intravesical adenoviral gene therapy
- Class: Antineoplastic cell and gene therapy
- ATC: L01XL10
- EU approval: 28 May 2026
- Label revised: 23 Jun 2026
- Status: conditional approval, advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/adstiladrin-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/adstiladrin-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/adstiladrin

Mechanism (SmPC section 5.1): A non-replicating adenovirus vector enters bladder tumour cells and urothelium, causing them to express IFNα2b protein without integrating into the genome; the text names no molecular target.

## Label wording

- **Nadofaragene firadenovec** (Adstiladrin), Urothelial carcinoma, early: “ADSTILADRIN is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/adstiladrin-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/nadofaragene-firadenovec