Nadofaragene firadenovec, sold under the brand name Adstiladrin, is a gene therapy used to treat high-risk bladder cancer. It consists of a non-replicating adenoviral vector that delivers the gene for interferon alfa-2b directly into the bladder through a catheter, prompting bladder cells to produce the interferon protein and mount an immune response against tumor cells. It is indicated for adults with high-risk, Bacillus Calmette-Guerin unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. In its pivotal trial, about half of participants achieved a complete response, with some maintaining that response for a year or more. The United States Food and Drug Administration approved it in December 2022. It is developed and marketed by Ferring Pharmaceuticals A/S.
Facts
Classification
Approval Status ATC ClassSourced to the subject's own accountL: Antineoplastic and Immunomodulating Agents 2 First Approved / Isolated Year Sources
1. Nadofaragene firadenovec (Wikipedia)
Lead section, approval-status statementQuote, Lead section, approval-status statement
Nadofaragene firadenovec was approved for medical use in the United States in December 2022, and in the European Union in May 2026.
View the Source 2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code LQuote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
View the Source 3. Drugs.com: Adstiladrin (nadofaragene firadenovec-vncg) FDA Approval History
FDA Approval HistoryQuote, FDA Approval History
Adstiladrin (nadofaragene firadenovec-vncg) was first approved by the FDA on December 16, 2022
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