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Accelerated Approval and Emerging Surrogate Endpoints
Session Chair(s)
Julie Lepin, MA
Vice President, Regulatory Affairs Oncology
Amgen, United States
Accelerated drug approval pathways may allow investigational cancer drugs to be approved early by demonstrating a favorable benefit-risk profile based on a surrogate endpoint (e.g., progression-free survival) that is expected to predict a real clinical benefit (e.g., overall survival). Typically, once a drug is approved under this pathway, it must undergo postapproval confirmatory studies to evaluate the actual clinical benefit . As oncology therapies become more effective and targeted, clinical trials are becoming more difficult to enroll and conduct. Traditional endpoints like overall survival become untenable due to the availability of patients to participate in the study and the amount of time needed to demonstrate a statistically significant difference. Extended development times delay the ability to get new and innovative therapies to patients, and, at the pace of new molecule development, risk making effective therapies obsolete before they ever get approved. Surrogate endpoints are important, even critical, tools in improving how cancer drugs are developed and evaluated. This session will focus on the successes and challenges of various accelerated approval mechanisms and discuss the regulatory and clinical challenges of new and innovative surrogate endpoints that may soon be used to provide patients with early access to new and innovative therapies.
Learning Objective : Describe successes and challenges of various accelerated approval mechanisms; Discuss regulatory and clinical challenges of new and innovative surrogate endpoints.
Speaker(s)
FDA Update
Patricia Keegan, MD
TopAlliance Biosciences, United States
Chief Medical Officer and Senior Vice President
Health Canada Update
Kelly Robinson, MSc
Health Canada, Canada
Director General, Marketed Health Products Directorate
EMA Update
Falk Ehmann, MD, PhD, MS
Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Head of Innovation and Development Accelerator – ad interim
Academic Update
C. Ola Landgren, MD, PhD
Memorial Sloan Kettering Cancer Center, United States
Professor of Medicine and Chief of Myeloma Service
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