Nice post, S. Re the FDA recognizing biomarkers
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Posted On: 05/18/2025 5:14:46 AM
Nice post, S.
Re the FDA recognizing biomarkers like CTC, CAML, and PD-L1 levels:
I bet we've all seen the FDA's language re what constitutes a surrogate endpoint in granting regulatory approval, but here it is again, below.
It seems that lowering CTCs and CAMLs IS indisputably likely to predict clinical benefit, but they are not yet accepted as predictive biomarkers. This has gotta change!
(PD-L1s seem a less direct route to clinical benefit -- Leron raises them so ICIs will work, but PD-L1 expression by itself doesn't mean a patient is getting better.)
Re the FDA recognizing biomarkers like CTC, CAML, and PD-L1 levels:
I bet we've all seen the FDA's language re what constitutes a surrogate endpoint in granting regulatory approval, but here it is again, below.
Quote:
DA may grant marketing approval for a new drug product [by] establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity
It seems that lowering CTCs and CAMLs IS indisputably likely to predict clinical benefit, but they are not yet accepted as predictive biomarkers. This has gotta change!
(PD-L1s seem a less direct route to clinical benefit -- Leron raises them so ICIs will work, but PD-L1 expression by itself doesn't mean a patient is getting better.)
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