February 14, 2006

US to look for early signs of cancer drug effects

By Lisa Richwine

WASHINGTON (Reuters) - Scientists will search for better
and earlier signs that a patient is likely to respond to a
cancer-fighting drug, or suffer toxic side effects, under a
U.S. program announced on Tuesday.

Three federal agencies will join together to identify
biological indicators, or "biomarkers," that can be analyzed in
blood, tissue or other samples, or through imaging scans.

Biomarkers already are part of drug development, but health
officials said they want to spark much broader applications. If
valid biomarkers are identified, drug companies could routinely
incorporate those measurements into their clinical trials.

"It seems like, to many of us, that tremendous
opportunities are being wasted right now because trials are
being done, and those trials could be used as vehicles to study
and qualify biomarkers," said Dr. Janet Woodcock, the Food and
Drug Administration's deputy commissioner for operations.

The FDA is collaborating with the National Cancer Institute
and the Centers for Medicare and Medicaid Services on the
effort. Drug companies and private foundations soon may sign on
to pool data and funding, Woodcock told reporters.

The first project will test if a technology known as
FDG-PET scanning, which measures cell metabolism, can predict
which patients with non-Hodgkin's lymphoma fare well with drug

That prediction could allow some patients to stop therapy
earlier, and avoid harsh side effects from additional
chemotherapy, health officials said.

"If we could predict early response, it would be a huge
advantage to patients," said Anna Barker, deputy director of
the National Cancer Institute.

Drug companies also could use newly discovered biomarkers
to get experimental cancer medicines to the market more
quickly, without waiting for tests to show if patients actually
live longer. Manufacturers are supposed to follow up after
approval to make sure a treatment does extend survival, but
many of those tests go unfinished.

Along with quicker approval, drug companies could see their
potential pool of patients shrink, Woodcock said.

"This is what we hope to see. We hope to see a narrowing of
the target population to people who are going to benefit," she

The drug industry said it welcomed the plan. "This is an
excellent beginning toward looking at ways to getting patients
the best medicine that works for them," said Mark Grayson, a
spokesman for the Pharmaceutical Research and Manufacturers of