Julia A. Beaver, MD
More than a third of the new indications for oncology drugs that became available for patient care during the past 25 years entered clinical practice as a result of the FDA’s accelerated approval (AA) program, an expedited review process that relies on surrogate endpoints to predict benefit before clinical trials are fully conducted. The use of the program has grown over the years, so much so that more new cancer drugs and indications gained approval through the AA pathway than through the regular review process during the first 6 months of 2017.
Endpoints Have Evolved
Much of the controversy about the AA program stems from a broader debate about appropriate endpoints for oncology clinical trials. Since the FDA began requiring clinical trials for new drug approvals in 1962, the gold standard for any new drug approval (not just cancer drugs) has been a randomized clinical trial that demonstrates an improvement in survival or important clinical symptoms. However, surrogate endpoints have been used, such as improvements in blood pressure or serum cholesterol for cardiovascular disease studies.2
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