BCAN 2019: FDA Approval of Therapies in the Context of BCG Shortages and Alternative Therapies

Washington, DC (UroToday.com) Seth Lerner, MD, FACS, from the Baylor College of Medicine in Houston, TX discussed FDA approval of therapies in the context of BCG shortages and alternative therapies. Definitions are important particularly with well-defined endpoints and disease states. Dr. Lerner discussed ongoing clinical trials including the SWOG 1602 (Prime) trial comparing strains of BCG including TICE v Tokyo strains for primary high-risk non-muscle invasive bladder cancer (NMIBC). Such trials are pivotal in order to offset current and future shortages of BCG. Furthermore, the ongoing debate with the FDA about clinical trial enrollment is whether patients receiving inadequate BCG especially in times of shortages (i.e. 1/3 dose) should be allowed to enroll in clinical trials. Further clarification on these patients is needed to improve clinical trial enrollment. 

Presented by: Seth Lerner, MD, FACS, Beth and Dave Swaim Chair in Urologic Oncology, Baylor College of Medicine, Houston, TX 

Written by: Stephen B. Williams, MD, Medical Director for High Value Care; Chief of Urology, Associate Professor, Director of Urologic Oncology, Director Urologic Research, The University of Texas Medical Branch at Galveston, TX and Ashish M. Kamat, MD, Professor, Department of Urology, Division of Surgery, The University of Texas, MD Anderson Cancer Center, Houston, TX at the 2019 Bladder Cancer Advocacy Network (BCAN) Think Tank August 8-10, 2019 - the Capital Hilton, Washington, DC, USA