The potential of predictive biomarkers for the development of stratified medicine has been highlighted for more than a decade. The current situation is very concrete. In Europe, EMA has accepted 49 biomarker-indication-drug combinations over 16 years, mostly used in cancer and as a predictive of drug efficacy, and in a minor scale of drug toxicity (4 cases).
These data confirm that currently the new wave of "personalised" or stratified medicine is really minor, although the investments and return expectations are huge.
Given the large body of literature documenting research into potential predictive biomarkers and extensive investment into stratified medicine, we identified relatively few predictive biomarkers included in licensing. These were also limited to a small number of clinical areas.
