Adstiladrin FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 21, 2022.
FDA Approved: Yes (First approved December 16, 2022)
Brand name: Adstiladrin
Generic name: nadofaragene firadenovec-vncg
Dosage form: Suspension for Intravesical Use
Company: Ferring Pharmaceuticals Inc.
Treatment for: Bladder Cancer
Adstiladrin (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus CalmetteGuérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
- Adstiladrin works by delivering the interferon alfa-2b gene into the cells of the bladder wall, which results in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer.
- Adstiladrin is instilled into the bladder once every three months.
- Warnings and precautions associated with Adstiladrin include risk of disseminated adenovirus infection in people who are immunocompromised or immunodeficient.
- Common adverse reactions include instillation site discharge, fatigue, bladder spasm, micturition (urination urgency), hematuria (blood in urine), chills, pyrexia (fever), and dysuria (painful urination). Common laboratory abnormalities include increased glucose, increased triglycerides, increased creatinine, and decreased phosphate levels.
Development timeline for Adstiladrin
| Date | Article |
|---|---|
| Dec 16, 2022 | Approval FDA Approves Adstiladrin (nadofaragene firadenovec-vncg) for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer |
Further information
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