Half of cancer drugs that receive accelerated approval fail in subsequent trials

SAN DIEGO – For decades, the Food and Drug Administration’s accelerated approval process has helped companies get drugs for serious unmet medical needs to patients – and to the market – sooner. But about half of cancer drugs approved through this route fail to improve patient survival or quality of life in subsequent clinical trials after more than five years of follow-upaccording to new findings presented Sunday at the annual meeting of the American Association for Cancer Research.

The data comes from an analysis of cancer drugs that have seen accelerated approval over the past decade. In some cases, the failure to demonstrate clinical benefit has not prevented the FDA from converting accelerated approvals to full approvals, and the authors note that the agency’s conversion decisions are increasingly based on less stringent evidence of the benefits of a medicine.

The study also found evidence that drugs granted accelerated approval, intended as a temporary designation, spend less time in limbo. In 2013, it took an average of 9.9 years after accelerated approval of cancer drugs were withdrawn from the market if follow-up studies showed no benefit; by 2017, that timing had dropped to 3.6 years.