As Senior Vice President and Chief Medical Officer of the American Society of Clinical Oncology, Dr. Schilsky is involved in professional and patient education, quality improvement, policy and advocacy, communications, clinical research and development of CancerLinQ, ASCO’s rapid learning system for oncology. Prior to joining ASCO, Dr. Schilsky was a faculty member at the University of Chicago from 1984-2012. He served as Director of the University of Chicago Cancer Research Center (1991-99), as Associate Dean for Clinical Research (1999-2007) and as Chief of the Section of Hematology-Oncology (2009-2012). He presently serves as a member of the Board of Directors of the Reagan-Udall Foundation for the FDA, of Friends of Cancer Research and of the National Coalition for Cancer Research, and as a member of the National Cancer Policy Forum of the National Academy of Medicine. Dr. Schilsky has served as a member of the Board of Directors of ASCO and of the Conquer Cancer Foundation of ASCO and as ASCO President 2008-2009.
Immunotherapy drugs have resulted in multiple firsts including a large number of accelerated approvals and new ways of classifying biomarkers. Recent articles questioned the validity of current FDA programs for rapid cancer drug approval, suggesting that they may be flawed. This panel will review FDA’s Accelerated Approval, Breakthrough Therapy, Fast Track, and Priority Review programs, why the programs were created, how they address the needs and wishes of patients and families, and some of the points that the FDA failed to consider.