http://www.fda.gov/bbs/topics/news/2006/NEW01316.html

Press Release

New Federal Health
Initiative to Improve Cancer Therapy
Patients will Benefit from Rapid Development and
Delivery of New Cancer Treatments

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.

FDA Critical Path

Critical Path is the FDA';s premier initiative to identify and
prioritize the most pressing medical product development problems and
the greatest opportunities for rapid improvement in public health
benefits. Its primary purpose is to ensure that basic scientific
discoveries translate more rapidly into new and better medical
treatments by creating new tools to find answers about how the safety
and effectiveness of new medical products can be demonstrated in faster
timeframes with more certainty and at lower costs.

The NIH Roadmap

The NIH Roadmap is a series of new initiatives designed to pursue
major opportunities and gaps in biomedical research that no single NIH
institute could tackle alone, but which the agency as a whole can
address to make the biggest impact possible on the progress of medical
research, and to catalyze changes that will serve to transform new
scientific knowledge into tangible benefits for public health.
Additional information about the NIH Roadmap can be found at its Web
site, www.nihroadmap.nih.gov.

For information about the Food and Drug Administration, please visit
http://www.fda.gov.
For additional information about the National Cancer Institute, please
visit http://www.cancer.gov.
For information about the Centers for Medicare & Medicaid Services,
please visit http://cms.hhs.gov.

FDA/NCI/CMS
Memorandum of Understanding

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