February 15, 2006

The FDA has launched an interagency initiative, along with the NIH and the Centers for Medicare & Medicaid Services (CMS), to develop personalized cancer treatments and accelerate cancer drug approvals through the use of biomarkers.

The Oncology Biomarker Qualification Initiative (OBQI), which is being developed under the rubric of the agency's Critical Path Initiative, will use clinical trials to develop and evaluate biomarkers to identify which drugs are most effective in treating cancer. Biomarkers are biologic indicators of disease or therapeutic effects of a treatment, measured through imaging tests and tests on blood, tissue and other biologic samples.

The goal of OBQI is to validate particular biomarkers so they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients, the FDA said.

The biomarkers will be used to determine: which populations are at greatest risk from cancer; what drugs will work best on certain populations; an individual's risk of cancer reoccurring; and potential side effects. Having this data will ensure that drug development is more efficient and will help sponsors assess a drug's safety and effectiveness, Janet Woodcock, FDA's deputy commissioner for operations, said during a recent conference call announcing the project.

Under the OBQI, the FDA will provide the data necessary to understand challenges facing the cancer drug pipeline, while the National Cancer Institute (NCI) will provide its scientific expertise, said Woodcock. CMS Administrator Mark McClellan noted the collaboration will produce evidence that will help people with Medicare and Medicaid get better care more quickly, as a result of better-targeted treatment decisions for cancer patients.

The first OBQI project will validate and standardize the use of Fluorodeoxyglucose -- Positron Emission Tomography (FDG-PET) scanning. PET scans are used to characterize biochemical changes in a cancer. Under the collaboration, researchers will use FDG-PET imaging technology in trials of patients being treated for non-Hodgkin's lymphoma, to determine if FDG-PET is a predictor of tumor response. Data resulting from this type of evidence-based study will help both the FDA and the CMS work with drug developers based on a common understanding of the roles of these types of assessments.

The goal of the initiative is to transform preclinical and clinical drug development by taking a more scientific approach that will result in greater predictability, Woodcock said. "I can't emphasize enough" the need to move toward a more scientifically sound approach, she added. "The development process is fraught with uncertainty."