Video of Trinity J Bivalacqua, MD, PhD, about the definition of BCG in NMIBC

Definition of BCG Unresponsive

Trinity J. Bivalacqua, MD, PhD, Professor of Urology and Oncology at the Perelman Center for Advanced Medicine, University of Pennsylvania discusses the development of the definition of BCG unresponsive disease and how this has helped in the development of clinical trials and drugs being approved for this disease.

Transcript: In 2015, the FDA asked a number of urologists at GU ASCO to come up with a definition for patients who either, or had BCG relapsing refractory disease. There was no real terminology or standardized terminology to help design new clinical trials for the advent of new therapeutic drugs, either intravesical or systemic drugs that were coming into the market. So a group of urologists came together and came up with a definition, which has now been adapted, which is called BCG-unresponsive disease. This is very important because it helps us be able to standardize the groups of patients that are ultimately being enrolled in clinical trials and regulatory approval for things like KEYTRUDA, which has recently received FDA approval for nonmuscle invasive bladder cancer, which is BCG-unresponsive CIS.