A: THE FDA’S RECENT APPROVAL of Merck’s pembrolizumab (Keytruda) represents the next generation of regulatory advancements in policy recognizing the importance of specific biomarkers rather than the tumor’s location in the body. It is important to point out that the FDA and the biopharmaceutical industry have been moving in this direction over several years, particularly in the area of oncology where more than 20 percent of the NMEs (new molecular entities) approved by the FDA (over the last three years) have had a personalized medicine approach. The importance of “pathway” over “tumor location” will impact the entire healthcare ecosystem: all stakeholders will need to evolve to a more personalized approach to ensure access to these new ground-breaking medications for the hope of better outcomes for all patients.
JOHN HUBBARD, PH.D.
John is a board member of Agile Therapeutics and has over three decades of experience including executive level positions with Pfizer, ICON, PAREXEL, and Hoechst Marion Roussel Pharmaceuticals.