U.S. FDA Approves Second Drug Product Manufacturing Facility for ADSTILADRIN® (nadofaragene firadenovec-vncg)
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Ferring expands production of ADSTILADRIN with new
Parsippany, NJ , facility, adding to existing manufacturing sites in Kuopio,Finland - Capacity expansion and diversification of manufacturing footprint further ensures stable and sustainable supply to meet the anticipated growth in global demand for ADSTILADRIN
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Milestone prompts final
payment from Royalty Pharma$200 million
ADSTILADRIN is 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). Bladder cancer is the sixth most diagnosed cancer in
“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, 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.”
Located on Ferring’s
“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 data2 and data from our Japan Phase 3 trial3 — 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.”
About ADSTILADRIN
ADSTILADRIN® (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of 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. It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.
ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment.4 The pivotal Phase 3 study met its primary endpoint, with more than half (
Earlier this month, Ferring announced results from an ongoing Phase 3 trial of ADSTILADRIN in BCG-unresponsive CIS ± high-grade Ta/T1 patients (n=20) in
Ferring is leading the future in uro-oncology treatment with ADSTILADRIN at the center, while expanding access with the support of new, state-of-the-art manufacturing facilities. As announced in January 2024, ADSTILADRIN is fully available and accessible in the
About Ferring Uro-Oncology
Ferring is committed to investing in novel therapies, developing life-changing solutions that address unmet medical needs, and aiding the uro-oncology community in helping patients live better lives. More information is available in the
About Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.6 In
INDICATION
ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of 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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.
WARNINGS AND PRECAUTIONS:
- Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
- Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.
DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration.
USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.
ADVERSE REACTIONS: The most common (>
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.
Please click to see the full Prescribing Information.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In
For more information, please visit www.ferringusa.com, call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X.
References:
- 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.
- 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.
- 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
- ADSTILADRIN in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Gov Identifier: NCT02773849. Available at: https://clinicaltrials.gov/ct2/show/NCT02773849. Accessed April 22, 2025.
- Ferring Access Support benefits investigations for commercial and government-insured patients through March 15, 2024.
- Urology Care Foundation. Non-muscle Invasive Bladder Cancer. Available at: https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed April 22, 2025.
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National Cancer Institute. Cancer Statistics. Available at: https://www.cancer.gov/about-cancer/understanding/statistics#:~:text=The%20most%20common%20cancers%
20% 28listed%20in%20descending%20order,pancreatic%20cancer%2C%20leukemia%2C%20thyroid%20cancer%2C%20and%20liver%20cancer. Accessed April 22, 2025. - Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022 Jan;81(1):75-94.
- Lidagoster S, et al. BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. Curr Oncol. 2024 Feb 16;31(2):1063-1078. doi: 10.3390/curroncol31020079.
- National Comprehensive Cancer Network. Bladder Cancer (Version 1.2025). Available at: https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed April 22, 2025.
More information is available at the following:
- Healthcare Providers: If you are interested in ordering ADSTILADRIN, please sign up for information and updates at www.ADSTILADRINHCP.com.
- Patients and Consumers: For more information about ADSTILADRIN, please visit www.ADSTILADRIN.com, or call 1-888-FERRING (888-337-7464), and select option number one.
- Media: Members of the press can contact Carol Ready, Director, Brand Communications by phone at (973) 765-7307, or email at carol.ready@ferring.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250424910916/en/
Carol Ready
Director, Brand Communications
(973) 765-7307
carol.ready@ferring.com
Source: Ferring Pharmaceuticals