Adstiladrin (nadofaragene firadenovec)

ATMPConditionalAdditional monitoring

Region: 🇪🇺 EU
Active substance: nadofaragene firadenovec
Company: Ferring Pharmaceuticals A/S
Status: Authorised
Therapeutic area: Non-Muscle Invasive Bladder Neoplasms
CHMP opinion: Thu 26 Mar 2026
EU approval: Thu 28 May 2026
Designations: ATMP, Conditional, Additional monitoring
Application: EMEA/H/C/005856
ATC: L01XL10
Official record: www.ema.europa.eu

Indication

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.

Regulatory milestones

Thu 28 May 2026🇪🇺 EU approval (EC decision)

Adstiladrin (nadofaragene firadenovec) approved in the EU

Marketing authorisation to Ferring Pharmaceuticals A/S; ATMP, Conditional, Additional monitoring · source

Thu 26 Mar 2026🇪🇺 CHMP positive opinion

Adstiladrin (nadofaragene firadenovec): CHMP positive opinion

Ferring Pharmaceuticals A/S; ATMP, Conditional, Additional monitoring · source

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.