The first gene therapy for bladder cancer


Dr Veena Aggarwal, Consultant Womens’ Health, CMD and Editor-in-Chief, IJCP Group & Medtalks Trustee, Dr KK’s Heart Care Foundation of India    20 December 2022

Patients with high-risk non-muscle-invasive bladder cancer (NMIBC) not responding to intravesical Bacillus Calmette-Guérin (BCG) therapy now have a new treatment alternative to cystectomy, which has almost always been their only treatment option. The US Food and Drug Administration (FDA) has approved the first gene therapy “nadofaragene firadenovec-vncg” for the treatment of adult patients with high-risk BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors.1,2


Nadofaragene firadenovec-vncg, available as Adstiladrin, is a non-replicating adenoviral vector based gene therapy and is instilled into the bladder through a urinary catheter once every three months for one year. “The adenovirus vector enters the cells of the bladder wall, releasing a gene that directs the cells to secrete high quantities of interferon alfa-2b, a naturally occurring cancer-fighting protein”.2


Contraindication: Immunosuppressed patients or those with immunodeficiency


Side effects: Fatigue, chills, fever, bladder discharge, bladder spasm, urgency, hematuria, dysuria.


Nadofaragene firadenovec-vncg is expected to be available in 2023, in the later part of the year. The cost of the therapy is yet to be revealed.




  1. FDA news release. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-high-risk-non-muscle-invasive-bladder-cancer, Dec. 16, 2022. Accessed on Dec. 19, 2022.
  2. FDA approves first gene therapy for bladder cancer - Medscape - Dec 16, 2022.

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