Many cancer patients and oncologists may turn to the US Food and Drug Administration’s accelerated approval program, which provides access to new cancer drugs faster – especially when a life-threatening cancer needs swift treatment or relief.
Yet a new study questions the clinical benefit of some drugs in the program and suggests ways in which the program could be improved.
The FDA recently facilitated the use of what’s called “surrogate endpoints” when studying a new drug for approval or accelerated approval.
A surrogate endpoint serves as a way to measure the impact of a drug without waiting to collect real clinical data on outcomes such as survival.
So a patient might not necessarily live longer, and their symptoms might not appear to be improving, but that surrogate endpoint – such as how many patients saw their tumors shrink – may be an easier or earlier measurement to assess.