Posted by Michael Wonder on 10 Sep 2023
The accelerated approval program for cancer drugs — finding the right balance
9 September 2023 - Implementation of the accelerated approval program has been rocky in recent years.
Studies of this pathway have documented issues such as surrogate measures of questionable validity being used for approval decisions, long waits for completion of confirmatory trials, use of unvalidated surrogate measures instead of clinical end points in confirmatory trials, delays in FDA action when confirmatory trials don’t show evidence of clinical benefit, treatment effects that are statistically significant but not clinically meaningful, and exceptionally high prices for drugs approved under the program.
