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Drugs and Medicinal Substances

Nadofaragene firadenovec

Antineoplastic and Immunomodulating Agents

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
Approved 1
ATC ClassSourced to the subject's own account
L: Antineoplastic and Immunomodulating Agents 2
First Approved / Isolated Year
2022 3
Sources
1. Nadofaragene firadenovec (Wikipedia)
Lead section, approval-status statement
Quote, 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.
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code L
Quote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
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3. Drugs.com: Adstiladrin (nadofaragene firadenovec-vncg) FDA Approval History
FDA Approval History
Quote, FDA Approval History
Adstiladrin (nadofaragene firadenovec-vncg) was first approved by the FDA on December 16, 2022
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