Use of Multiple Endpoints and Approval Paths Depicts a Decade of FDA Oncology Drug Approvals

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 10 years, two thirds of oncology regular approvals were based on endpoints other than overall survival. More than three quarters of accelerated approvals were based on response rates. The accelerated approval program has been heavily used 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 U. S. Food and Drug Administration and drug sponsors have used over the past decade in the development of new treatments for cancer. (C) 2013 AACR.