• Accelerated water-bath thawing, completed in about 25 minutes, may help streamline clinical workflows and support efficient patient management
• Label update includes data showing that product stability is maintained with the 25-minute, 25° C water-bath method
• Label update reinforces Ferring’s commitment to improving patient and provider experience through continued innovation in the delivery and handling of ADSTILADRIN

Ferring Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved a label update for ADSTILADRIN^® (nadofaragene firadenovec-vncg), enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams.

ADSTILADRIN is the first and only FDA-approved non-replicating intravesical gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1). In the United States, bladder cancer is the sixth most common cancer, with NMIBC comprising about 75% of all new cases.^1,2

"The reduction in thawing time for ADSTILADRIN streamlines preparation and handling for healthcare providers treating patients with high-risk non-muscle invasive bladder cancer," said Vikram M. Narayan, MD, FACS, Associate Professor at Emory University Department of Urology, Chief of Urology at Grady Memorial Hospital. “This updated preparation process has the potential to save valuable time and enable healthcare providers and practices to deliver this treatment option to more patients efficiently.”

ADSTILADRIN is shipped and stored as a sterile frozen suspension and must be brought to room temperature (20° C to 25° C [68° F to 77° F]) prior to use. The FDA’s approval is supported by a thawing and handling study demonstrating that frozen vials remained stable when thawed for about 25 minutes in a water bath maintained at 25°C (77°F). The storage conditions for ADSTILADRIN remain unchanged once thawing begins and permit storage for up to 24 hours at room temperature or up to 7 days refrigerated (2-8°C), including thaw time.

"At Ferring, we remain deeply committed to evolving our therapies in ways that address the real-world needs of patients and the healthcare providers who care for them," said Denise D’Andrea, MD, FACP, Senior Director, Medical Affairs Uro-Oncology, Ferring Pharmaceuticals. "ADSTILADRIN already offers convenient, once-every-three-months dosing that helps reduce visit frequency, travel burden and clinic workflow demands. The new 25 minutes at 25°C thaw option provides additional flexibility and represents another important step in our ongoing efforts to streamline operational workflow across care settings.”

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,¹ fourth among men,⁴ and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.⁴ Historically, 75% of bladder cancer presents as NMIBC.² 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.⁵ 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).⁶

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 (±Ta/T1). 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).^7-8

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) carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).

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 increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition (urination urgency), increased creatinine, hematuria (blood in urine), decreased phosphate, chills, pyrexia (fever) and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit http://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, 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:

1. National Cancer Institute. Cancer Statistics. https://www.cancer.gov/about-cancer/understanding/statistics. Accessed February 2026.
2. 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. https://pubmed.ncbi.nlm.nih.gov/34511303/. Accessed February 2026.
3. Urology Care Foundation. Non-muscle Invasive Bladder Cancer. https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed February 2026.
4. American Cancer Society. Cancer Facts & Figures 2025. 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 February 2026.
5. 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. https://pubmed.ncbi.nlm.nih.gov/38392073/. Accessed February 2026.
6. National Comprehensive Cancer Network. Bladder Cancer (Version 1.2026). https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed March 2026.
7. ADSTILADRIN in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Gov Identifier: NCT02773849. https://clinicaltrials.gov/ct2/show/NCT02773849. Accessed February 2026.
8. 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. https://www.auajournals.org/doi/full/10.1097/JU.0000000000004020. Accessed February 2026.

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