Nadofaragene firadenovec

Generic Name
Nadofaragene firadenovec
Brand Names
Adstiladrin
Drug Type
Biotech
Chemical Formula
-
CAS Number
1823059-12-6
Unique Ingredient Identifier
0OOS09O1FH
Background

Nadofaragene firadenovec (nadofaragene firadenovec-vncg) is a recombinant non-replicating adenovirus serotype 5 vector containing a transgene encoding human interferon alfa-2b (IFNα2b). It was approved by the FDA on December 2022 for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcino...

Indication

Nadofaragene firadenovec is indicated for the treatment of adult patients with high-risk Bacillus CalmetteGuérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Associated Conditions
High risk BCG-unresponsive non-muscle invasive bladder cancer
Associated Therapies
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urotoday.com
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Managing BCG-Unresponsive NMIBC: Treatment Strategies, Progression, and Emerging Therapies

Discussions on novel treatments for BCG-unresponsive bladder cancer, including CD40 antibody, nadofaragene firadenovec, Anktiva (N-803), cretostimogene, and additional BCG, highlighting their efficacy and safety.
urologytimes.com
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Vikram Narayan, MD, on cystectomy outcomes in nadofaragene-treated patients

Dr. Vikram M. Narayan discusses a study on nadofaragene firadenovec-vncg treatment in BCG-unresponsive non–muscle-invasive bladder cancer, finding that 2/3 of patients with complete response at 3 months avoided cystectomy at 60 months, and only 6 of 44 cystectomy patients had muscle-invasive cancer.
bioprocessintl.com
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Ferring bolsters Adstiladrin production with Finland expansion

Ferring's 25,000 sqm facility, approved by FDA in June 2023, produces adenovirus vector-based gene therapy Adstiladrin. A fill/finish plant in New Jersey is nearing completion. The unit aims for LEED certification with sustainable energy solutions. Adstiladrin, FDA-approved in 2022, became fully available in the US in January 2024. Ferring partnered with SK pharmteco in April 2024 for commercial-manufacturing scale-up.
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