It stimulates the immune system to inhibit growth of—and eliminate—bladder cancer cells.1
What Is ADSTILADRIN?
ADSTILADRIN Is a Localized Gene Therapy Dosed
Once Every 3 Months
ADSTILADRIN IS…
A localized non-replicating gene therapy
A monotherapy instilled directly into the bladder
It works alone—no Bacillus Calmette-Guérin (BCG) coadministration is required.1
Instilled ONCE EVERY
3 MONTHS
It is the only quarterly dosed, FDA-approved high-risk non–muscle-invasive bladder cancer (NMIBC)
treatment. This reduces appointment frequency for you and your patients.1-5
Effective in long-term follow-up and real-world use
5-year clinical trial data and real-world evidence support the efficacy and safety of ADSTILADRIN.6,7
Well tolerated
It is administered locally, which may reduce adverse events (AEs). In clinical trials, AEs were transient, local, and lasted a median duration of <2
days.1,3,8-10*
ADSTILADRIN IS NOT…
Chemotherapy
Some patients may develop resistance to chemotherapy over time.11
Replicating or modifying genes
ADSTILADRIN does not alter existing genes in the body.1,12
A treatment with limited duration for use
Patients may continue
treatment with ADSTILADRIN for as long as they respond.1,6
Limited by physician-only treatment administration
Most licensed medical professionals and urologists can administer ADSTILADRIN right in the urology office.1
Reliant on an implanted drug delivery system
It is not a foreign body requiring insertion, retention, and extraction.1
Choose ADSTILADRIN FIRST for your patients with
BCG-
unresponsive NMIBC1
Clinical Leave Behind Download
Keep key information about ADSTILADRIN (nadofaragene firadenovec-vncg) handy with this helpful resource
*With the exception of fatigue and pollakiuria (frequent daytime urination).10
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Form ToggleReferences: 1. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; October 2025. 2. Patel SH, Gabrielson A, Collins C, et al. Intravesical gemcitabine and docetaxel in the treatment of BCG-naïve non–muscle invasive urothelial carcinoma of the bladder: updates from a phase 2 trial. J Clin Oncol. 2023;41(suppl 6):507. doi:10.1200/JCO.2023.41.6_suppl.507 3. Keytruda. Prescribing information. Merck & Co, Inc; 2024. 4. Anktiva. Prescribing information. ImmunityBio, Inc; 2024. 5. TICE BCG. Package insert. Merck & Co, Inc; 2022. 6. 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. doi:10.1097/JU.0000000000004020 7. Moyer JA, Durant A, Nguyen M, et al. Real-world outcomes of nadofaragene firadenovec in BCG-unresponsive non-muscle invasive bladder cancer. Poster presented at: 2025 ASCO Genitourinary Cancers Symposium. February 13-15, 2025; San Francisco, CA. 8. Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol. 2021;22(1):107-117. doi:10.1016/S1470-2045(20)30540-4 9. Deininger S, Törzsök P, Mitterberger M, et al. From interferon to checkpoint inhibition therapy—a systematic review of new immune-modulating agents in Bacillus Calmette–Guérin (BCG) refractory non-muscle-invasive bladder cancer (NMIBC). Cancers. 2022;14(3):694. doi:10.3390/cancers14030694 10. Data on file. Ferring Pharmaceuticals, Inc. July 2024. 11. Lu CS, Shieh GS, Wang CT, et al. Chemotherapeutics-induced Oct4 expression contributes to drug resistance and tumor recurrence in bladder cancer. Oncotarget. 2017;8(19):30844-30858. doi:10.18632/oncotarget.9602 12. Narayan VM, Dinney CPN. Intravesical gene therapy. Urol Clin North Am. 2020;47(1):93-101. doi:10.1016/j.ucl.2019.09.011
Important Safety Information
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. Visit www.FDA.gov/medwatch or call 1-800-332-10881-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING1-888-FERRING.
Please see full Prescribing Information for ADSTILADRIN.