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# Ferring Gene Therapy Scale-Up Approved
- URL: https://www.fdaweb.com/ferring-gene-therapy-scale-up-approved/
- Published: 2023-06-12T12:00:00.000Z
- Updated: 2026-09-14T18:38:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154673

FDA has approved a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin (nadofaragene firadenovec-vncg) and the company’s plan to scale-up its drug substance manufacturing process at FinVector Oy located in Kuopio, Finland. The company says supplies from the scale-up process manufactured at FinVector’s facility will be available as part of its planned product launch later this year. The gene therapy was approved 12/2022 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.

The gene therapy’s approval was 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, an agency [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) says. “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.