Effectiveness of FDA accelerated approval for cancer drugs

 A recent assessment published in the JAMA has reviewed the cases of 93 cancer drug indications granted accelerated approval by the FDA from December 11, 1992, through May 31, 2017. Confirmatory trials reported that 20% (n = 19) produced an improvement in overall survival, whilst in other cases, benefits were limited to surrogate measures. Few of these drugs approved via the accelerated FDA approval pathway had verified benefits based reflected in improvement in survival. The FDA accelerated approval pathway allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (e.g. progression-free survival) that is expected to predict a real clinical benefit (e.g. overall survival), but the drugs must undergo post-approval confirmatory studies to evaluate actual clinical benefits. In an interesting debate, the authors suggest that perhaps the system warrants reassessment? Read more here