Bladder cancer accounts for approximately 90% to 95% of all new cases of urothelial cancer in the United States, with a prevalence of approximately 700,000. Bladder cancers are described as non-muscle invasive (NMIBC) or muscle-invasive based on whether or not they have invaded into the wall of the bladder. NMIBC accounts for approximately 80% of all new cases of bladder cancer diagnosed in the United States each year, which corresponds to an estimated annual incidence and prevalence of approximately 60,000 and 500,000 cases, respectively. Overall, approximately 70% of patients with NMIBC present with low-grade disease at diagnosis. The current standard of care for treating NMIBC patients is transurethral resection of the bladder tumor (TURBT) followed by adjuvant chemotherapy or immunotherapy at the discretion of the treating physician. TURBT is a surgical operation for tumor removal performed using a special scope and conducted under anesthesia in a hospital setting and is associated with risks such as bleeding, injury to the bladder and infection. Relapse of disease is common after TURBT (30-40% at one year and up to 70% at five years following surgery); and, it is not unusual for patients to require multiple surgical procedures to control NMIBC over a lifetime making bladder cancer the costliest cancer to treat in the United States. No drugs have been approved by the FDA as first-line treatment for NMIBC and only three drugs have been approved for NMIBC, all used as adjuvant treatment.
UGN-102, an RTGel™-based formulation of mitomycin, is our investigational product candidate for the treatment of LG NMIBC. UGN-102 is administered locally using standard catheters and is designed to conform to the bladder’s anatomy and persist in the bladder despite urine flow and bladder movement. UroGen is currently enrolling patients in a Phase 2b study to further investigate UGN-102 in the treatment of intermediate risk LG NMIBC.