Increasingly new cancer drugs, thought by the FDA to show enough evidence of improved outcomes, navigate a short cut in the approval process, with accelerated approval allowing clinical use.
This study looks at 129 such drugs and reviews the benefit after 5 years, with correlation to confirmatory trials.
Results from the study suggest that the majority (67%) of these drugs do not improve survival or the quality of life. Despite this many of these drugs received full unqualified approval later.
The Authors suggest that informed consent should be obtained prior to use of the drugs in this category of accelerated approval, and that confirmatory trials should be undertaken before the limited approval is extended or converted.
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