ADSTILADRIN IS FULLY AVAILABLE.
Your FIRST choice 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
A Guideline-Recommended Treatment
Nadofaragene firadenovec-vncg (ADSTILADRIN) is a recommended treatment option in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)* and the AUA/SUO Guidelines1
Locally
Localized, non-replicating gene therapy, offering a
well-tolerated safety profile2-5
- 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
- 0 grade 4 or 5 drug-related reactions‡
- 2% of patients discontinued treatment due to ARs
- No new safety signals out to 5 years
Quarterly
Intravesical instillation
once every 3 months2
- No Bacillus Calmette-Guérin (BCG) coadministration required
- Seamless integration into your existing management of non–muscle-invasive bladder cancer (NMIBC), reducing the treatment burden
Confidently
Proven and durable
complete responses (CRs)
and bladder preservation2,4,5
- 51% of the carcinoma in situ (CIS) cohort achieved CR by month 3 (after only 1 instillation)
- The cystectomy-free survival rate at 5 years was ≈1/2 for patients in the CIS cohort (n=103)§
Confirmed coverage
and reimbursement6¶
*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.4.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 1, 2024. 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).3
‡3.8% of patients experienced grade 3 reactions out to 60 months.5
§The Kaplan-Meier estimated cystectomy-free survival rate for the CIS cohort was 43% at 5 years.5
¶ADSTILADRIN has confirmed 99% coverage for commercial and government-insured patients.6
Abbreviations: 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.
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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. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; August 2024. 3. Data on file. ADSTILADRIN CSR, Ferring Inc. Parsippany, NJ. 4. 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 5. 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 6. 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.