Introduction: The current first line therapy for high grade (HG) non-muscle invasive bladder cancer (NMIBC) is intravesical Bacillus Calmette-Guerin (BCG). Patients who recur or progress despite BCG are recommended to undergo radical cystectomy or participate in clinical trials.
As our molecular understanding of bladder cancer continues to advance, more and more novel agents are entering clinical trials across the spectrum of bladder cancer stages. The clinical trial activity for non-muscle invasive bladder cancer (NMIBC) has been boosted further by the evolution of specific disease states that set more uniform inclusion criteria for clinical trial design.
BCG is the gold standard agent used in high-risk non-muscle-invasive bladder cancer (NMIBC) that is amenable to bladder sparing management. However, recent BCG shortages appear to be a chronic problem.
Due to the high rate of recurrence and progression in patients with high-risk non-muscle-invasive bladder cancer (NMIBC), there exists an important unmet need to identify new therapies. This is especially the case for patients recurring after optimal intravesical bacillus Calmette-Guérin (BCG), who are classified as having BCG-unresponsive disease.
Intravesical immunotherapy with bacille Calmette-Guérin (BCG) vaccine is the main treatment for non-muscle-invasive bladder cancer (NMIBC), with proven effects on reducing recurrence, progression, and death from NMIBC.
Adjuvant intravesical instillations with bacillus Calmette-Guérin (BCG) is the recommended treatment option for patients with intermediate-and high-risk non-muscle invasive bladder cancer (NMIBC).
Non-muscle-invasive bladder cancer is a challenging disease to treat, with few effective salvage intravesical options available for patients who develop bacillus Calmette-Guerin-unresponsive disease.
Due to significant risks of cancer recurrence and progression, and limited options after intravesical Bacillus Calmette Guerin (BCG) therapy, there is a critical unmet need to identify novel treatments for those patients with BCG-unresponsive bladder cancer.
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