FDA is undertaking a spectrum of initiatives to encourage the development of drugs and medical products linked to patient subtypes. At a briefing to unveil a new report on these activities, commissioner Margaret Hamburg discussed how a deeper understanding of the underlying mechanisms of disease has made it possible for FDA to approve new cancer drugs for patients with specifically characterized tumors, as well as a new treatment for cystic fibrosis effective in patients with a specific gene mutation. Agency researchers are developing methods for refining dosing regimens by examining genetic factors that may affect how much of a drug enters the blood stream. Richard Pazdur, director of FDA’s Center for Drug Evaluation and Research’s Office of Oncology & Hematology products, predicted that smaller clinical trials for targeted cancer treatments will be possible by using platforms for universal testing of known biomarkers. “Paving the Way for Personalized Medicine” is available at www.fda.gov.
