Imaging, Other Biomarkers Focus of Health Initiative

The Oncology Biomarker Qualification Initiative (OBQI) is a recent collaboration by U.S agencies towards improving the development of cancer therapies and the outcomes for cancer patients through biomarker development and assessment. Biomarkers are biologic indicators of disease or therapeutic effects, which can be determined through dynamic imaging modalities, as well as tests on blood, tissue, and other biologic samples.

This initiative is the first time three specific US Department of Health and Human Services (HHS) agencies have focused together on biomarkers as a way of speeding the development and evaluation of cancer therapies. The agencies are: the U.S. Food and Drug Administration (FDA; Rockville, MD, USA), the U.S. National Cancer Institute (NCI; Bethesda, MD, USA), part of the National Institutes of Health (NIH), and the Centers for Medicare & Medicaid Services (CMS; Baltimore, MD, USA).

The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. Specifically, the OBQI will address questions such as how specific biomarkers can be utilized to: (1) assess after one or two treatments if a patient's tumor is responding to treatment; (2) determine more definitively if a tumor is dying, even if it is not shrinking; (3) identify which cancer patients are at high risk of their tumor coming back after therapy; (4) determine if a patient's tumor will respond at all to a specific treatment; and (5) effectively assess whether an investigational therapy is effective for tumor treatment.

The goal of OBQI is to validate specific biomarkers so that they can be used to evaluate new, promising methods in a way 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 suitability of drug choices for cancer patients.

The first OBQI project to be implemented will serve to validate and standardize the use of fluorodeoxyglucose positron emission tomography (FDG-PET) scanning. PET scans are utilized to characterize biochemical alterations in tumors. 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 sort of evidence-based research will help both the FDA and CMS work with drug developers based on a common understanding of the roles of these types of assessments.



Related Links:
U.S. National Cancer Institute