FDA Workshop: Contemporary Issues in Non-Muscle Invasive Bladder Cancer (NMIBC) Trial Design and Interpretation

The FDA Oncology Center of Excellence is convening a workshop to explore critical issues in NMIBC trial design and interpretation. This session will bring together perspectives from molecular biology, clinical pathology, urology, and medical oncology to examine key scientific and clinical considerations. Key discussion topics: · Similarities and differences between papillary and carcinoma in situ histology in NMIBC—and their implications for demonstrating efficacy in clinical trials. · The current Bacillus Calmette-Guérin (BCG) shortage and its impact on clinical trial design.