ADSTILADRIN IS FULLY AVAILABLE.
Choose ADSTILADRIN FIRST
for patients with high-risk NMIBC after BCG
GENERATE THE FIGHT WITHIN
ADSTILADRIN is the FIRST and ONLY FDA-approved intravesical non-replicating gene therapy for high-risk NMIBC
Nadofaragene firadenovec-
vncg (ADSTILADRIN) is
A recommended treatment option:
- In the NCCN Clinical
Practice Guidelines in
Oncology (NCCN
Guidelines®)* and the AUA/
SUO Guidelines1 - By the International
Bladder Cancer Group
(IBCG) for high-risk NMIBC
after BCG failure for those
seeking
to avoid radical
cystectomy2
Locally
Localized, non-replicating gene therapy, offering
a
well-tolerated safety profile3-6
- 75% of adverse reactions (ARs)
were mild (grades 1 and 2) and resolved within 2 days†- Serious ARs occurred in 11% of patients
who received ADSTILADRIN - No grade 4 or 5 drug-related reactions‡
- Serious ARs occurred in 11% of patients
- 2% of patients discontinued treatment due to ARs
- Chemo free and nonsystemic
- No new safety signals out to
5 years
Quarterly
The only intravesical
instillation given
once every
3 months3,6
- No Bacillus Calmette-Guérin
(BCG) coadministration
or foreign body system required - Seamless integration into your existing management
of non–
muscle-invasive bladder cancer (NMIBC), reducing the treatment burden - Patients may continue quarterly maintenance treatment
as long as they respond
Confidently
5-year clinical data and real-world evidence support the efficacy and safety of ADSTILADRIN3,6-8
IN THE CS-003 CLINICAL TRIAL:
- 51% of the carcinoma in situ (CIS) cohort achieved CR by month 3
(after only 1 instillation)§ - Of the patients who achieved
a CR, 13 out of 55
underwent
a cystectomy within the 5-year
follow-up||
INTERIM RESULTS FROM AN ONGOING PHASE 3
TRIAL (JAPAN):
- 75% of the CIS cohort achieved
CR at month 3 (n=15)
IN A REAL-WORLD RETROSPECTIVE STUDY:
- The 3-month CR rate for the CIS
was 79% (n=24)¶
ADSTILADRIN can help patients preserve their bladder
Confirmed coverage
and reimbursement9#
*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for
Bladder Cancer V.1.2025. © National Comprehensive Cancer Network, Inc. 2025.
All rights reserved. Accessed
October 10, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.
NCCN makes no warranties of any kind whatsoever
regarding their content, use or application and disclaims
any responsibility for their application or use in any way.
†With the exception of fatigue and pollakiuria (frequent daytime urination).4
‡3.8% of patients experienced grade 3 reactions out to 60 months.6
§Based on patients (n=50) who achieved a CR; CR reflects period from the time CR was achieved.3
||Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.
This exploratory analysis is not in the Prescribing Information. It is being provided for descriptive purposes;
results require cautious interpretation, as radical cystectomy may have been
performed after patient
discontinuation.
¶Data represent the true proportion of patients with a CR at 3 months.77
#ADSTILADRIN has confirmed 99% coverage for commercial and government-insured patients.9
AUA, American Urological Association; SUO, Society of Urologic Oncology. NCCN, National Comprehensive
Cancer Network® (NCCN®).
ADSTILADRIN in Practice
Neal Shore, MD, FACS, a clinician from the ADSTILADRIN clinical trials, discusses key treatment information, including preparation, administration, and more.
Sign Up to Receive Information and Updates on ADSTILADRIN (nadofaragene firadenovec-vncg)
Form ToggleReferences: 1. Holzbeierlein J, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. J Urol. 2024;211(4):533-538. doi:10.1097/JU.0000000000003846 2. Li R, Hensley PJ, Gupta S, et al. Bladder-sparing therapy for Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection. Eur Urol. 2024;86(6):516-527. doi:10.1016/ j.eururo.2024.08.001 3. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; October 2025. 4. Data on file. ADSTILADRIN CSR, Ferring Inc. Parsippany, NJ. 5. 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 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. Jakobsen J. Efficacy and safety of nadofaragene firadenovec for BCG-unresponsive non-muscular-invasive bladder cancer: initial results from an ongoing Japanese phase 3 trial. Presented at: 112th Annual Meeting of the Japanese Urological Association. April 17-19; Fukuoka, Japan. 9. Ferring Access Support benefits investigations for commercial and government-
insured patients through March 15, 2024.
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.