Bishal Gyawali, Associate Professor at Queen’s University, shared a post on LinkedIn:
“Yesterday FDA issued one wrong and one right approval.
pCR is a prognostic marker not a predictive marker of treatment benefit. Drug approval based on pCR is not science based.
Additionally, DB11 is a classic case of overpowered trial. They failed to meet their own stated goal of 15% improvement in pCR but this 11% difference was nevertheless significant because of overpowered trial. Approval of neoadjuvant TDXd based on DB11 is not an evidence based decision. For more on this, watch this video.
However approval of adjuvant atezolizumab based on ctDNA is right.
There is a difference between these two.
Prognostic vs predictive biomarkers.
Many people don’t understand this difference.
We have a paper coming out soon to explain this.”
Other articles about FDA on OncoDaily.