of patients fail Bacillus Calmette-Guérin (BCG)
treatment, with about half of those failures
occurring within the first 6 months2,3
About NMIBC
There Is a Need for
a Well-Tolerated, Noninvasive Treatment That Prevents NMIBC Progression
BCG maintenance, a
first-line treatment, may fail to
prevent recurrence
or progression1
≈50%
≈30%
of patients with non–muscle-invasive bladder cancer (NMIBC) will progress to muscle-invasive bladder cancer, with high-risk
NMIBC patients with carcinoma in situ (CIS) facing the greatest risk
of progression4,5
)
Some precystectomy treatments may bring
unique burdens
- Systemic NMIBC regimens (eg, intravenous infusions) may cause systemic toxicity and more severe adverse events
(AEs) than localized treatments6-10 - Some intravesical therapies may be frequent or invasive, causing bladder fatigue
- Some treatments require BCG coadministration, as well
as frequent induction and maintenance doses10-12 - Intravesical devices may cause urinary tract AEs (urinary
tract infections, urethral syndrome) and be difficult to
place for
some anatomy13
- Some treatments require BCG coadministration, as well
- Patients may develop resistance to chemotherapy
options over time, leading to recurrence or bladder
cancer progression14
)
Patients prefer bladder preservation over radical cystectomy15
Although a guideline-recommended treatment, radical cystectomy is a life-altering procedure that may result in negative outcomes, including16,17:
- Short-term morbidity and mortality, including postsurgical complications (gastrointestinal issues, infection)18-20
- Impacted quality of life15
Cystectomy may be contraindicated for
patients with severe comorbidities or frailty
due
to age or other factors that increase
surgical risk21
)
Gene therapy helps fight cancer by bolstering
an immune response22
The bladder is an ideal organ for gene therapy because
it offers:
- Direct contact between the gene vector and tumor cells23,24
- Local administration, which limits systemic exposure and AEs24
- Easy access to monitor effects of therapy22
ADSTILADRIN is a localized, non-replicating gene
therapy
with a well-tolerated safety profile.
When BCG fails, make ADSTILADRIN your first choice for
bladder preservation.
Is Your Patient With NMIBC Right for ADSTILADRIN?
Neal Shore, MD, FACS, a clinician from the ADSTILADRIN clinical trials, shares information about patient identification for ADSTILADRIN.
Sign Up to Receive Information and Updates on ADSTILADRIN (nadofaragene firadenovec-vncg)
Form ToggleReferences: 1. Lidagoster S, Ben-David R, De Leon B, Sfakianos JP. BCG and alternative therapies to BCG therapy for non-muscle-invasive bladder cancer. Curr Oncol. 2024;31(2):1063-1078. doi:10.3390/curroncol31020079 2. Kamat AM, Flaig TW, Grossman HB, et al. Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer. Nat Rev Urol. 2015;12(4):225-235. doi:10.1038/nrurol.2015.58 3. Meng MV, Gschwend JE, Shore N, Grossfeld GD, Mostafid H, Black PC. Emerging immunotherapy options for bacillus Calmette-Guérin unresponsive nonmuscle invasive bladder cancer. J Urol. 2019;202(6):1111-1119. doi:10.1097/JU.0000000000000297 4. Boegemann M, Krabbe LM. Prognostic implications of immunohistochemical biomarkers in non-muscle-invasive blad cancer and muscle-invasive bladder cancer. Mini Rev Med Chem. 2020;20(12):1133-1152. doi:10.2174/1389557516666160512151202 5. Filon M, Schmidt B. New treatment options for non–muscle-invasive bladder cancer. Am Soc Clin Oncol Educ Book. 2025;45(2). doi:10.1200/EDBK-25-471942 6. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; October 2025. 7. 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 8. Deininger S, T.rzs.k 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 9. Li R, Sundi D, Zhang J, et al. Systematic review of the therapeutic efficacy of bladder-preserving treatments for non–muscle-invasive bladder cancer following intravesical Bacillus Calmette-Guérin. Eur Urol. 2020;78(3):387-399. doi:10.1016/j.eururo.2020.02.012 10. Keytruda. Prescribing information. Merck & Co, Inc; 2024. 11. Anktiva. Prescribing information. ImmunityBio, Inc; 2024. 12. 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 13. Daneshmand S, Brummelhuis ISG, Pohar KS, et al. The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial. Urol Oncol. 2022;40(7):344.e1-344.e9. doi:10.1016/j.urolonc.2022.02.009 14. 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 15. Collacott H, Krucien N, Heidenreich S, Catto JWF, Ghatnekar O. Patient preferences for treatment of Bacillus Calmette-Guérin-unresponsive non–muscle-invasive bladder cancer: a cross-country choice experiment. Eur Urol Open Sci. 2023;49:92-99. doi:10.1016/j.euros.2022.12.016 16. Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on non–muscle-invasive bladder cancer (Ta, T1, and carcinoma in situ). Eur Urol. 2022;81(1):75-94. doi:10.1016/j.eururo.2021.08.010 17. Berger I, Xia L, Wirtalla C, Dowzicky P, Guzzo TJ, Kelz RR. 30-day readmission after radical cystectomy: identifying targets for improvement using the phases of surgical care. Can Urol Assoc J. 2019;13(7):E190-E201. doi:10.5489/cuaj.5455 18. Maibom SL, Joensen UN, Poulsen AM, Kehlet H, Brasso K, R.der MA. Short-term morbidity and mortality following radical cystectomy: a systematic review. BMJ Open. 2021;11(4):e043266. doi:10.1136/bmjopen-2020-043266 19. Cinar NB, Yilmaz H, Avci IE, Cakmak K, Teke K, Dillioglugil O. Reporting perioperative complications of radical cystectomy: the influence of using standard methodology based on ICARUS and EAU quality criteria. World J Surg Oncol. 2023;21(1):58. doi:10.1186/s12957-023-02943-9 20. Kobayashi K, Goel A, Coelho MP, et al. Complications of ileal conduits after radical cystectomy: interventional radiologic management. Radiographics. 2021;41(1):249-267. doi:10.1148/rg.2021200067 21. Lee M, Eun DD. Robotic radical cystectomy of the bladder. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Accessed August 21, 2025. https://www.ncbi.nlm.nih.gov/books/NBK604466/ 22. Amer MH. Gene therapy for cancer: present status and future perspective. Mol Cell Ther. 2014;2:27.doi:10.1186/2052-8426-2-27 23. Narayan VM, Dinney CPN. Intravesical gene therapy. Urol Clin North Am. 2020;47(1):93-101. doi:10.1016/j.ucl.2019.09.011 24. Mahendran R, Tham SM, Esuvaranathan K. Gene therapy in urology. InTech. 2011. doi:10.5772/22235 25. 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
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.