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# FDA OK’s Ferring’s Bladder Cancer Gene Therapy
- URL: https://www.fdaweb.com/fda-oks-ferrings-bladder-cancer-gene-therapy/
- Published: 2022-12-16T12:00:00.000Z
- Updated: 2026-09-14T18:10:03.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153421

FDA has approved a Ferring Pharmaceuticals BLA for Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector‑based gene therapy indicated for treating adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Approval is based on safety and effectiveness data from a multicenter clinical study that included 157 patients with high-risk BCG-unresponsive NMIBC, 98 of whom had BCG-unresponsive CIS with or without papillary tumors, the agency says in a [release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-high-risk-non-muscle-invasive-bladder-cancer?ref=fdaweb.com). “Overall, 51% of enrolled patients using Adstiladrin therapy achieved a complete response (the disappearance of all signs of cancer as seen on cystoscopy, biopsied tissue, and urine),” it says. The median duration of response was 9.7 months, and 46% of responding patients remained in complete response for at least one year.