Use of Multiple Endpoints and Approval Paths Depicts a Decade of FDA Oncology Drug Approvals
Menée sur la période 2002-2012, cet article analyse l'évolution des différents critères de jugement utilisés pour l'autorisation accélérée de mise sur le marché des médicaments anticancéreux aux Etats-Unis
This study explores the historic use of different endpoints to support regular and accelerated approval of cancer drugs between 2002 and 2012. In the past ten years, two thirds of oncology regular approvals were based on endpoints other than overall survival. Over three quarters of accelerated approvals were based on response rates. The accelerated approval program has been heavily utilized over this time period, with one third of all approved oncology indications receiving accelerated approval. At times, critics have characterized the agency as rigid and unpredictable. This research describes the degree of regulatory flexibility that FDA and drug sponsors have used over the past decade in the development of new treatments for cancer.
Clinical Cancer Research , résumé, 2013