Posted by Michael Wonder on 22 Jun 2019
Should the FDA speed up or slow down approval of new cancer drugs?
21 June 2019 - Earlier this month, the FDA announced the creation of Project Facilitate.
This pilot program facilitates access to innovative treatments for cancer that have not yet been approved by individuals who aren’t able to enrol in clinical trials. This move suggests that the FDA finds the approval process for cancer drugs to be too slow.
At the same time, some experts want the FDA to slow down the approval process for cancer treatments. A recent article in JAMA Internal Medicine argued that cancer drugs are receiving accelerated approval without sufficient evidence proving they are safe and effective. More specifically, the article raised concerns over the widespread use of surrogate outcomes to measure treatment efficacy.
Surrogate outcomes, such as progression-free survival and treatment response rate, are imperfectly correlated with overall survival. The authors suggest that the FDA is approving cancer drugs too quickly, as these surrogate endpoints may not provide sufficient evidence of improved long-term survival.
