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Review
. 2023 Mar;83(4):353-357.
doi: 10.1007/s40265-023-01846-z.

Nadofaragene Firadenovec: First Approval

Arnold Lee  1
Affiliations
Review

Nadofaragene Firadenovec: First Approval

Arnold Lee. Drugs. 2023 Mar.

Erratum in

Abstract

Nadofaragene firadenovec (nadofaragene firadenovec-vncg; Adstiladrin®) is a non-replicating adenoviral vector-based gene therapy developed by Ferring Pharmaceuticals for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). Nadofaragene firadenovec constitutes vector DNA that encodes for interferon (IFN)-α2b and is the first approved gene therapy in bladder cancer. The production of IFN-α2b by transfected urothelial cells is associated with anticancer activity, including immunostimulatory, antiangiogenic and apoptotic effects. In December 2022, nadofaragene firadenovec received its first global approval in the USA for the treatment of high-risk BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumours in adults. This article summarizes the milestones in the development of nadofaragene firadenovec leading to this first approval for this indication.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Arnold Lee is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Figures

None
Key milestones in the development of nadofaragene firadenovec. BLA biologics license application, NMIBC non-muscle-invasive bladder cancer
See this image and copyright information in PMC

References

    1. U.S. Food & Drug Administration. FDA approves first gene therapy for the treatment of high-risk, non-muscle-invasive bladder cancer [media release]. 16 Dec 2022. https://www.fda.gov/.
    1. Narayan VM, Dinney CPN. Intravesical gene therapy. Urol Clin North Am. 2020;47(1):93–101. doi: 10.1016/j.ucl.2019.09.011. - DOI - PMC - PubMed
    1. Ferring Pharmaceuticals. Ferring receives approval from U.S. FDA for Adstiladrin for high-risk, BCG-unresponsive non-muscle invasive bladder cancer [media release]. 16 Dec 2022. https://www.ferring.com/.
    1. US National Institutes of Health. ClinicalTrials.gov trial record (NCT03710876). 2021. https://clinicaltrials.gov/. Accessed 7 Feb 2023.
    1. Ferring Pharmaceuticals. ADSTILADRIN® (nadofaragene firadenovec-vncg) suspension, for intravesical use: US prescribing information. 2022. https://www.fda.gov/. Accessed 27 Jan 2023.

MeSH terms