Ferring Expands Growing Body of Real-World Evidence Reinforcing Use of ADSTILADRIN® (nadofaragene firadenovec-vncg) in Urology Practices

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1:40 PM on Thursday, October 16

The Associated Press

PARSIPPANY, N.J.--(BUSINESS WIRE)--Oct 16, 2025--

Ferring Pharmaceuticals announced today additional evidence from the real-world experience of a private urology practice assessing the efficacy and safety of ADSTILADRIN ® (nadofaragene firadenovec-vncg) in 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).

The data – presented at the 99th Annual Meeting of the North Central Section of the AUA in Chicago, IL – showed a complete response (CR) rate of 77% (10/13) at 3 months, including 70% in patients with CIS± papillary tumors (7/10) and 100% (3/3) in those with papillary-only lesions.

Thirteen patients met entry criteria with a mean age of 77.7 years. Pretreatment pathology showed 10 CIS± papillary tumors and 3 papillary-only lesions. Patients received a median of 12 prior BCG doses (range 6-19). Nadofaragene firadenovec was administered intravesically 75 mL (3×10¹¹ viral particles/mL) and retained for 1 hour. All patients were premedicated with oral vibegron 75 mg, a treatment for overactive bladder and nearly all patients (12/13) retained the medication in their bladder for the full hour.

“The Phase 3 ADSTILADRIN research provides strong evidence for its efficacy and safety, but urologists and their patients also want to understand how these results translate to routine clinical practice,” said John Eifler, M.D., a urologist at First Urology in Louisville, KY. “In our real-world study, we observed a three-month efficacy rate that exceeded the Phase 3 findings, underscoring the role of ADSTILADRIN as an effective and well-tolerated option for BCG-unresponsive patients.”

"These new data add to the growing body of real-world evidence in urology practices offering patients a bladder-sparing, non-chemotherapy option after BCG fails," said Daniel A. Shoskes, MD, FRCS(C), Vice President, Global Medical Director-Uro-Oncology, Ferring Pharmaceuticals. “Real-world research, including studies supported by Ferring, help to reinforce the efficacy and safety of ADSTILADRIN demonstrated in prospective trials and provide uro-oncologists the information needed to help guide critical treatment decisions.”

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 (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology® ). 1-2

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 U.S. at FerringUroOncology.com and on the dedicated Ferring Uro-Oncology channels on LinkedIn and X.

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. 3 In the United States, bladder cancer is the sixth most common cancer, 4 fourth among men, 5 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025. 5 Historically, 75% of bladder cancer presents as NMIBC. 6 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care. However, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease. 7 Current treatment options for BCG-unresponsive patients are very limited, and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder). 8

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 (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visitwww.FDA.gov/medwatchor 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, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees.

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:

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 October 15, 2025.
Narayan VM, Boorjian SA, Alemozaffar M, et al. Efficacy of intravesical nadofaragene firadenovec for patients with Bacillus Calmette-Guérin-unresponsive nonmuscle-invasive bladder cancer: 5-year follow-up from a phase 3 trial. J Urol. 2024;212(1):1-12.
Urology Care Foundation. Non-muscle Invasive Bladder Cancer. Available at: https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed October 15, 2025.
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 October 15, 2025.
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 October 15, 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.
National Comprehensive Cancer Network. Bladder Cancer (Version 4.2024). Available at: https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed October 15, 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 [email protected].