FDA head says U.S. plans to speed cancer drug evaluations

Input from experts at the National Cancer Institute has helped U.S. regulators review cancer medicines more quickly, and they hope to use the idea to speed other drug evaluations, Food and Drug Administration Commissioner Mark McClellan said on Saturday.

The FDA gained valuable advice by exchanging personnel with the NCI, part of the government-funded National Institutes of Health, which conducts clinical trials and funds outside research, McClellan told a conference. The FDA surprised investors in May with swift approval of Millennium Pharmaceuticals Inc.’s Velcade for multiple myeloma in less than four months. It also cleared a novel therapy for lung cancer, AstraZeneca Plc’s Iressa, in May. “I think you have seen some major achievements by FDA just in recent months,” McClellan told the American Association of Cancer Research. “One of the reasons some of those approvals could take place…was because of the input of experts at NCI. It’s a model we’d like to apply more widely, including to prostate cancer.” The FDA will reveal more details “in a week or so” on new performance standards for drug reviews that also are part of McClellan’s plans to help expedite the process, he said.(Source: Reuters Health: July 14, 2003: Oncolink)