Bishal Gyawali, Medical Oncologist and Professor at Queen’s University, shared his own post on X, adding:
“Another important highlight from our study is the underutilization of accelerated approval pathway.
AA pathway provides a good balance between speed and evidence. But what we found is that most approvals based on surrogate endpoints in recent years is in fact regular approval rather than AA. An upfront premature RA removes the safety net of confirmatory trial requirement that verifies clinical benefit. It also removes the safety net of withdrawing drugs that don’t benefit patients. AA pathway exists for a reason.
There is zero logic to providing regular approval instead of AA based on weak surrogate endpoints.”
Title: Cancer Medicine Approvals in the US
Authors: Brian Shkabari, Nicole Vorko, Wesley Geerlinks, Elizaveta Purh, Claire Diana-Gonsalves, Svasti Sutaria, Bishal Gyawali
Read the Full Article on JAMA
