nadofaragene firadenovec-vncg

FDA Drug Profile — ADSTILADRIN

Drug Details

Generic Name
nadofaragene firadenovec-vncg
Brand Names
ADSTILADRIN
Application Number
BLA125700
Sponsor
Ferring Pharmaceuticals Inc.
NDC Codes
2
Dosage Forms
SUSPENSION
Routes
INTRAVESICAL
Active Ingredients
NADOFARAGENE FIRADENOVEC

Indications and Usage

1 INDICATIONS AND USAGE ADSTILADRIN ® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )