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 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.
Avoid harsh side effects
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 treatment.
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 said.
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 America.
