Nadofaragene firadenovec

Nadofaragene firadenovec
Gene therapy
Target gene	Interferon alfa-2b
Clinical data
Trade names	Adstiladrin
Other names	Nadofaragene firadenovec-vncg, Instilidrin, rAd-IFN/Syn3
MedlinePlus	a623062
License data	US DailyMed: Nadofaragene firadenovec;
Routes of; administration	Intravesical
ATC code	L01XL10 (WHO) ;
Legal status
Legal status	US: ℞-only;
Identifiers
CAS Number	1823059-12-6;
PubChem SID	497620944;
DrugBank	DB17381;
UNII	0OOS09O1FH;
KEGG	D12531;

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 "Adstiladrin- nadofaragene firadenovec-vncg suspension". DailyMed. 30 October 2024. Retrieved 24 November 2024.
^ "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.

[Adstiladrin_FDA_label-1] "Adstiladrin- nadofaragene firadenovec-vncg suspension". DailyMed. 30 October 2024. Retrieved 24 November 2024.

[2] "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.

[FDA_PR_20221216-3] "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.

[FDA_Adstiladrin-4] "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.

[5] "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.

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