BCG Failure: Defining Failure and Managing Difficult Cases of Non-Muscle Invasive Bladder Cancer

Donald L. Lamm, MD, FACS, Director of BCG Oncology and Clinical Professor of Surgery at the University of Arizona College of Medicine, discusses the criteria required of studies looking for alternative drug therapies to Bacillus Calmette-Guerin (BCG) to treat non-muscle invasive bladder cancer (NMIBC). Because there are many BCG refractory, recurrent, intolerant, and unresponsive patients, and because there is a global shortage of BCG, new drugs are much needed. To get funding, studies will require FDA approval, and Dr. Lamm suggests that researchers are more likely to receive approval quickly by using standard definitions and providing clear follow-up and end-points in their proposals.

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