of high-risk NMIBC patients experience disease recurrence
within 1 year of currently available intravesical therapy.1
About NMIBC
There is a high unmet need in treating patients with NMIBC
>50%
≈50%
of patients will be unresponsive
to Bacillus Calmette-Guérin
(BCG) therapy2
≈30%
of NMIBC patients
will progress to muscle-invasive
bladder cancer3
)
Patients prefer a bladder-sparing option4
Radical cystectomy is the guideline recommendation for these patients,5 but it is associated with:
- Negative outcomes6
- Short-term morbidity and mortality7
- Postsurgery complications, including gastrointestinal issues and infection8,9
- Impacted quality of life4
There is a need for a well-tolerated localized treatment—post-BCG failure and before cystectomy—which allows patients to remain in the care of their urologist.
)
The bladder is an ideal organ for gene therapy
Gene therapy helps fight cancer by:
- Bolstering an immune response10,11
- Protecting healthy cells from the side effects of these treatments11
Key reasons the bladder is ideal for this type of therapy:
- Direct contact between the gene vector and tumor cells12,13
- Local administration limiting systemic exposure13
- Easy access to monitor effects of therapy11
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References: 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. 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 4. 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 5. 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 6. 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 7. 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 8. 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 9. 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 10. Das SK, Menezes ME, Bhatia S, et al. Gene therapies for cancer: strategies, challenges and successes. J Cell Physiol. 2015;230(2):259-271. doi:10.1002/jcp.24791 11. Amer MH. Gene therapy for cancer: present status and future perspective. Mol Cell Ther. 2014;2:27. doi:10.1186/2052-8426-2-27 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 13. Mahendran R, Mun S, Esuvaranath K. Gene therapy in urology. InTech. 2011. doi:10.5772/22235
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.