ADSTILADRIN nadofaragene firadenovec-vncg

Drug Class

Adenovirus vector-based gene therapy

Mechanism

Delivers the gene for human interferon alfa-2b to the bladder wall cells, prompting them to synthesize and secrete IFN-2b protein to trigger an immune attack against tumor cells.

Approved Indication

High-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors, per its FDA approval.

What This Means For Patients

ADSTILADRIN is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2022) — Sources

Pivotal Clinical Evidence

• Study CS-003 — Boorjian et al., Lancet Oncol 2021 (NCT02773849) — Sources

Sources

• https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-certain-patients-non-muscle-invasive-bladder-cancer
• https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/adstiladrin