Nadofaragene firadenovec
Nadofaragene firadenovec (Adstiladrin, Ferring Pharmaceuticals A/S) has 1 EU-approved indication in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Urothelial carcinoma1 | |||
None | Monotherapy | Any line early | Non-muscle-invasive only; BCG-unresponsive; carcinoma in situ (CIS) with or without papillary tumours |
Full text of section 4.1 (therapeutic indications)
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.
Label history
There is no record of changes to the Adstiladrin label that oncolabels can read yet. EMA publishes it some months after the first approval.