FDA Approves Additional Manufacturing Plant for Ferring’s Adstiladrin

The FDA has approved a new, 12,000 square-foot drug product manufacturing facility for Adstiladrin, Ferring Pharmaceuticals’ branded form of intravesical non-replicating gene therapy (nadofaragene firadenovec-vncg).1 Located in Parsippany, NJ, this approval exponentially grows the company's manufacturing services to three sites that will be working to provide ample Adstiladrin to patients. It also helps honor the last $200 million payment from Royalty Pharma, which was part of a previous, royalty-based financing deal.

Adstiladrin is considered the first and only intravesical non-replicating gene therapy approved by the FDA for 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 (±Ta/T1). According to the American Cancer Society, bladder cancer is the sixth most diagnosed cancer in the United States, with most patients being diagnosed with non-muscle invasive disease.2

“The FDA approval of our new manufacturing facility for Adstiladrin represents our unwavering dedication to delivering high-quality, innovative therapies at scale,” said Armin Metzger, executive vice president and chief technical operations officer, Ferring Pharmaceuticals. “This expansion and diversification of our manufacturing footprint will further ensure stable and sustainable supply of Adstiladrin to meet the anticipated growth in global demand.”

Ferring’s hub features a manufacturing suite, including modern tech and enough equipment to produce an additional source of supply for Adstiladrin.

“Adstiladrin has transformed the treatment landscape for BCG-unresponsive bladder cancer patients and drives Ferring’s continued growth in uro-oncology,” said Bipin Dalmia, global head of uro-oncology and urology franchise, Ferring Pharmaceuticals. “The growing body of clinical evidence for Adstiladrin—including the recently announced independent real-world data3 and data from our Japan Phase 3 trial4—underscores the impact of this therapy. The FDA’s approval of this additional manufacturing site is a testament to our commitment to make Adstiladrin globally available to every bladder cancer patient who needs it.”

References

1. US FDA Approves Second Drug Product Manufacturing Facility for Adstiladrin (nadofaragene firadenovec-vncg). Business Wire. April 24, 2025. Accessed April 28, 2025. https://www.businesswire.com/news/home/20250424910916/en/U.S.-FDA-Approves-Second-Drug-Product-Manufacturing-Facility-for-ADSTILADRIN-nadofaragene-firadenovec-vncg

2. American Cancer Society. Cancer Facts & Figures 2025. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Accessed April 22, 2025.

3. Moyer J, Durant A, Nguyen M. Real-world outcomes of nadofaragene firadenovec in BCG-unresponsive non-muscle invasive bladder cancer. Presented at the Annual Meeting of the American Society of Clinical Oncology GU, February 2025.

4. Inoue K, Kikuchi E, Nishiyama H, Nasu Y, et al. Efficacy and Safety of Nadofaragene Firadenovec for BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer: Initial Results From an Ongoing Japanese Phase 3 Trial. Presented at the 112th Annual Meeting of the Japanese Urological Association, April 22, 2025. Available at: https://www.micenavi.jp/jua2025/search/detail_program/id:2055