FDA Considers New Rules to Speed Up Confirmatory Trials of Cancer Drugs Granted Accelerated Approval

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Since 1992, the U.S. Food and Drug Administration has granted accelerated approval to 47 new indications for 35 cancer drugs and in more than half the cases—26 indications—further trials have confirmed the benefits of the drugs. But the agency has concerns about the length of time some drugs have remained on the market without confirmation of their benefits, according to a review article published online March 25 in the Journal of the National Cancer Institute . New requirements and fines are possible solutions say the authors, from FDA’s Office of Oncology Drug Products.

John R. Johnson, M.D., and colleagues reviewed the FDA's experience with the accelerated approval process from its beginning in 1992 to July 2010. Among the 26 indications that eventually received regular approval, the median time between accelerated approval and regular approval was 3.9 years and the average time was 4.7 years. These represent “substantial time savings in terms of earlier availability of drugs to patients,” the authors write.