The Food and Drug Administration (FDA), the National Cancer Institute (NCI), part of the National Institutes of Health, and the Centers for Medicare & Medicaid Services (CMS) today announced the Oncology Biomarker Qualification Initiative (OBQI) — an agreement to collaborate on improving the development of cancer therapies and the outcomes for cancer patients through biomarker development and evaluation.
Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests, as well as tests on blood, tissue and other biologic samples. This initiative is the first time these three 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.
“We are excited about this effort to speed the development and delivery of new cancer treatments for patients,” said Secretary of Health and Human Services Mike Leavitt. “By bringing together the scientific, regulatory and delivery expertise of these three agencies, we can bring targeted, more personalized cancer diagnostics, treatments and preventions to patients more rapidly.”
The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. For instance, OBQI will address questions such as how particular biomarkers can be used to:
-Assess after one or two treatments if a patient’s tumor is responding to treatment
-Determine more definitively if a tumor is dying, even if it is not shrinking
-Identify which cancer patients are at high risk of their tumor coming back after therapy
-Determine if a patient’;s tumor is likely to respond at all to a specific treatment
-Efficiently evaluate whether an investigational therapy is effective for tumor treatment.
-The goal of OBQI is to validate particular biomarkers so that 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.
“Almost four years ago, NIH set out to create a “roadmap” for 21st century medical research. Programs like OBQI will be central to that vision, not only because they will lead to vital discoveries about the biology of disease, but because they will be models for scientific collaboration,” said NIH Director Elias A. Zerhouni, M.D.
“An enhanced understanding of clinical biomarkers will help make the development of diagnostics and treatments more targeted, one of our most pressing goals under the Critical Path Initiative, FDA’;s program to modernize the medical product development process,” said FDA Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “We believe partnerships that help us standardize the use of new technologies are essential to refining the drug development process, so we can bring personalized medicines to patients more quickly and ultimately improve outcomes.”
Under the OBQI, biomarker research will be focused in four key areas: standardizing and evaluating imaging technologies to see in more detail how treatments are working, developing scientific bases for diagnostic assays to enable personalized treatments, instituting new trial designs to utilize biomarkers, and pooling data to ensure that key lessons are shared from one trial to another. By working with academic and industry scientists, as well as professional organizations, the OBQI teams can foster the development of key information on biomarkers through clinical trials.
“By identifying biomarkers for specific cancers and clinically evaluating them, researchers will have an evidence base for their use in targeted drug development and to determine which therapies are likely to work for patients before treatment selection,” said NCI Deputy Director Anna D. Barker, Ph.D. “Rather than waiting weeks to months to determine if a specific drug works for a patient, biomarkers could be used to monitor real-time treatment responses.”
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 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 FDA and CMS work with drug developers based on a common understanding of the roles of these types of assessments.
“There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients,” said CMS Administrator Mark B. McClellan, M.D., Ph.D. “This 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.”
Over the next several months, the OBQI team will design a number of initiatives to identify and clinically qualify other cancer biomarkers. The new initiatives will bring together scientists from many sources and address agency priorities identified through FDA’;s Critical Path and NIH’;s Roadmap Initiatives. The OBQI also represents the work of the NCI-FDA Interagency Oncology Task Force (IOTF). The IOTF is a collaboration between NCI and FDA to enhance the efficiency of clinical research and the scientific evaluation of new cancer treatments. The two agencies, along with CMS, share knowledge and resources to facilitate the development of new cancer drugs and diagnostics and speed their delivery to patients as safely and as cost-effectively as possible.