Two U.S. agencies are teaming up to accelerate the design and approval of cancer drugs--the National Cancer Institute (NCI) and Food and Drug Administration (FDA). They announced the initiative on 30 May at the annual American Society of Clinical Oncology meeting in Chicago, Illinois.
The new plan calls for developing improved biomarkers to help assess a drug's effectiveness, enhancing design and evaluation strategies for cancer-preventing medications, and introducing new endpoints for measuring the success of cancer drugs. These might include inhibiting certain enzymes or specific molecular targets. The agencies are also interested in identifying protein markers in the blood that might provide clues as to how a drug is working, which could enhance the design of clinical trials.
The effort fits with NCI director Andrew von Eschenbach's goal of eliminating death and suffering from cancer by 2015 (Science, 28 February, p. 1297). In addition, FDA, under its new director Mark McClellan, has also been exploring ways to assess whether or not a cancer drug is effective. The agency already relies on a number of endpoints, including survival, tumor shrinkage, and easing of symptoms.
Some observers worry that new endpoints could cause FDA's standards to slip: "Is this going to allow drugs to get on the market based on less rigorous studies?" asks Peter Lurie, deputy director of health research at Public Citizen, a Washington, D.C., advocacy group. Lurie is concerned about moving away from the basic index of efficacy--extended survival. But Richard Pazdur, director of FDA's cancer drug division, says that standards will hold firm. "We're not trying to subvert" the drug approval process, he says.