FDA Approval Summary: Nadofaragene Firadenovec-vncg for Bacillus Calmette–Guérin–Unresponsive Non–Muscle-Invasive Bladder Cancer

• Published in: Clinical cancer research Vol. 31; no. 7; pp. 1182 - 1185
• Main Authors: Colbert, Laronna, Jia, Yuxia, Sharma, Anurag, Hu, Jiang, Xu, Zhenzhen, Suzman, Daniel L., Das, Asha, Bross, Peter, Kluetz, Paul G., Fashoyin-Aje, Lola A.
• Format: Journal Article
• Language: English
• Published: United States 01.04.2025
• Subjects: Adenoviridae - genetics; Administration, Intravesical; Adult; Aged; Aged, 80 and over; BCG Vaccine - therapeutic use; Carcinoma in Situ - pathology; Carcinoma in Situ - therapy; Female; Genetic Therapy - methods; Genetic Vectors - administration & dosage; Genetic Vectors - genetics; Humans; Male; Middle Aged; Mycobacterium bovis; Non-Muscle Invasive Bladder Neoplasms; Treatment Outcome; United States; United States Food and Drug Administration; Urinary Bladder Neoplasms - genetics; Urinary Bladder Neoplasms - pathology; Urinary Bladder Neoplasms - therapy; United States

On December 16, 2022, the FDA approved the adenoviral vector–based gene therapy nadofaragene firadenovec-vncg (brand name Adstiladrin) 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...