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  • Adstiladrin receives orphan drug designation in Korea
  • by Eo, Yun-Ho | translator Alice Kang | Jun 18, 2025 05:59am
for bladder cancer, that lacks treatment option
A gene therapy for BCG-refractory high-risk non-muscle-invasive bladder cancer (NMIBC)
Approved in the US in 2022¡¦ achieved complete remission in clinical trial
The new bladder cancer drug Adstiladrin has been designated as an orphan drug in Korea.

The Ministry of Food and Drug Safety recently announced the news in a orphan drug designation announcement.

The specific indication for designation is ¡°treatment of BCG-refractory high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papilloma.¡±

Adstiladrin (nadofaragene firadenovec-vncg) received FDA approval in the United States in 2022.

This drug uses a non-replicating adenovirus vector to deliver the human interferon alpha-2b gene, inducing an immune response by directly expressing the protein within the bladder epithelium.

Adstiladrin demonstrated efficacy through t
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