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 an intravesical gene therapy designed to treat high-risk, BCG-unresponsive bladder cancer. It introduces a gene that causes bladder cells to produce interferon to stimulate a localized immune attack on cancer cells, available via Boao Lecheng's special channels.

Regulatory Approvals

• FDA — approved (2022) — source

Pivotal Clinical Evidence

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

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