Global InformationNadofaragene firadenovec information
| Gene therapy | |
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| Target gene | Interferon alfa-2b |
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| Trade names | Adstiladrin |
| Other names | Nadofaragene firadenovec-vncg, Instilidrin, rAd-IFN/Syn3 |
| License data |
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| Routes of administration | Intravesical |
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Nadofaragene firadenovec, sold under the brand name Adstiladrin, is a gene therapy for the treatment of bladder cancer.[1][3][4] It is a non-replicating (cannot multiply in human cells) adenoviral vector-based gene therapy.[3]
The most common adverse events including laboratory abnormalities, include increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition urgency, increased creatinine, hematuria, decreased phosphate, chills, dysuria, and pyrexia.[4]
Nadofaragene firadenovec was approved for medical use in the United States in December 2022.[3][4][5]
- ^ a b "Archived copy". Food and Drug Administration. Archived from the original on 17 December 2022. Retrieved 17 December 2022.
{{cite web}}: CS1 maint: archived copy as title (link) - ^ "Adstiladrin". U.S. Food and Drug Administration (FDA). 16 December 2022. STN: BLA 125700. Archived from the original on 17 December 2022. Retrieved 16 December 2022.
- ^ a b c "FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer" (Press release). U.S. Food and Drug Administration (FDA). 16 December 2022. Archived from the original on 16 December 2022. Retrieved 16 December 2022.
This article incorporates text from this source, which is in the public domain.
- ^ a b c "FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer". U.S. Food and Drug Administration (FDA). 19 December 2022. Archived from the original on 19 December 2022. Retrieved 19 December 2022. This article incorporates text from this source, which is in the public domain.
- ^ "Ferring Receives Approval from U.S. FDA for Adstiladrin for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer". Ferring Pharmaceuticals USA (Press release). 16 December 2022. Archived from the original on 17 December 2022. Retrieved 16 December 2022.
