Table 2 FDA biomarker classification based on contexts of use
Biomarker type | When biomarker is measured | What biomarker indicates |
|---|---|---|
Prognostic | Prior to treatment | Indicates (estimates) the risk or likelihood that a patient who receives no further cancer-directed therapy will experience a specified clinical outcome, such as recurrence, progression, or death |
Predictive | Prior to treatment | Interpreted with defined criteria to identify patients who are likely to benefit from a specific treatment compared to patients who do not meet the specified criteria |
Response indicator | During or after treatment | Demonstrates a pharmacological or physiological response to the treatment, but does not necessarily signify patient benefit. Examples are declines in prostate-specific antigen, measures of tumor shrinkage, or pharmacodynamic changes in a parameter to show the on-target effect of a drug as proof of mechanism or to optimize dosing |
Efficacy response (surrogate) | After treatment | Provides an early and accurate prediction of both a clinical end point, and the effects of the treatment on that end point |