of patients with high-risk non–muscle-invasive bladder cancer (NMIBC) experience disease recurrence within 1 year of currently available intravesical therapy1
About NMIBC
There Is a Need for a Well-Tolerated Localized Treatment for Patients With NMIBC
>50%
≈50%
of patients become unresponsive to Bacillus Calmette-Guérin (BCG) therapy2
)
There are limited treatment options post BCG, with no newly approved intravesical therapies over the last 20 years3,4:
- BCG maintenance may fail to improve outcomes5
- Current bladder-sparing intravesical chemotherapies have limited rigorous clinical evidence6,7
)
Patients prefer bladder preservation over radical cystectomy8
Radical cystectomy is the guideline-recommended surgical option for these patients,9 but it is associated with:
- Negative outcomes10
- Short-term morbidity and mortality11
- Postsurgery complications, including gastrointestinal issues and infection12,13
- Impacted quality of life8
ADSTILADRIN (nadofaragene firadenovec-vncg) is an outpatient option that can be administered when patients first become BCG unresponsive, allowing them to remain in the care of their urologist
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. 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 2. Kamat AM, Lerner SP, O’Donnell M, et al. Evidence-based assessment of current and emerging bladder-sparing therapies for non–muscle-invasive bladder cancer after Bacillus Calmette-Guerin therapy: a systematic review and meta-analysis. Eur Urol Onc. 2020;3(3):318-340. doi:10.1016/j.euo.2020.02.006 3. Al Hussein Al Awamlh B, Chang SS. Novel therapies for high-risk non-muscle invasive bladder cancer. Curr Oncol Rep. 2023;25(2):83-91. doi:10.1007/s11912-022-01350-9 4. Valstar. Prescribing information. Endo Pharmaceuticals, Inc; 2019. 5. Jiang S, Redelman-Sidi G. BCG in bladder cancer immunotherapy. Cancers (Basel). 2022;14(13):3073. doi:10.3390/cancers14133073 6. Packiam VT, Richards J, Schmautz M, Heidenreich A, Boorjian SA. The current landscape of salvage therapies for patients with bacillus Calmette-Guérin unresponsive nonmuscle invasive bladder cancer. Curr Opin Urol. 2021;31(3):178-187. doi:10.1097/MOU.0000000000000863 7. Valenza C, Antonarelli G, Giugliano F, et al. Emerging treatment landscape of non-muscle invasive bladder cancer. Expert Opin Biol Ther. 2022;22(6):717-734. doi:10.1080/14712598.2022.2082869 8. 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 9. 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 10. 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 11. Maibom SL, Joensen UN, Poulsen AM, Kehlet H, Brasso K, Røder MA. Short-term morbidity and mortality following radical cystectomy: a systematic review. BMJ Open. 2021;11(4):e043266. doi:10.1136/bmjopen-2020-043266 12. 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 13. 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
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.