Video of Ashish M Kamat, MD, MBBS, about the definition of  BCG-unresponsive

Definition of BCG Unresponsive

Ashish M. Kamat, MD, MBBS, Endowed Professor of Urologic Oncology (Surgery) and Cancer Research at University of Texas MD Anderson Cancer Center explains how the definition of BCG unresponsive disease came about and its impact clinical studies for patients with NMIBC.

Transcript: The definition of BCG unresponsive disease has undergone changes over many years, and it actually started at an AUA meeting many years ago, and then was modified and ratified by the AUA group, the GU ASCO Group led by Seth Lerner, the International Bladder Cancer Group, which I happen to lead, and it was ultimately adopted by the FDA as an amalgamation of all these recommendations. And why was this important? Well, it was important because prior to the actual definition of BCG unresponsiveness being formalized, a lot of investigators, a lot of pharmaceutical companies invested a lot of time and effort. And of course, patients invested a lot of time and effort doing clinical studies after BCG had not worked. But we couldn’t really make head or tail out of the results of those studies because there was no uniformity in the inclusion criteria, the patient selected the endpoints. And that’s why when the definition of BCG unresponsive disease was adopted and formalized in the FDA guidance document 2018, there was an explosion of clinical studies. And these studies now follow that paradigm for regulatory and approval processes.