The Ongoing Evolution of Endpoints in Oncology
Since the U.S. Food and Drug Administration’s 1992 adoption of accelerated drug approval regulation, manufacturers often have turned to surrogate endpoints to speed the market arrival of new agents with the potential to save or extend lives. Despite its “gold standard” status, overall survival is increasingly regarded as a flawed measure of efficacy in colorectal cancer and advanced breast cancer. Surrogate endpoints can speed the time necessary to bring new anticancer agents to market, though each surrogate has its advantages and disadvantages.
Albert Tzeel, MD, MHSA, FACPE, Market Medical Officer for Humana Inc’s Great Lakes Region, discusses the importance of understanding surrogate endpoints for managed care decision makers.