Has the FDA approved drugs or devices for market using biomarkers in imaging?
Yes. Numerous drugs for oncology have been approved using imaging biomarkers. In a recent publication by the FDA examining the criteria used for oncology drug approvals between 1990 2002 by the FDA s Center for Drug Evaluation and Research, a majority of the drugs were found to be approved on the basis of imaging surrogate endpoints (see J. R. Johnson, G. Williams, R. Pazdur, End points and United States Food and Drug Administration Approval of Oncology Drugs, J. Clinical Oncology, 21(7), 1404-11, 1 April 2003). Numerous non-oncology examples also exist, including Betaseron, a drug designed to treat multiple sclerosis, was approved largely on the basis of MRI images that demonstrated improvement in brain lesions believed to be associated with the disease.
