Leading cancer research organization urges FDA to speed approval of drugs for precancers

Boston, MA (October 15 2002) The American Association for Cancer Research (AACR) today called for the federal government to open a new front in the war on cancer by speeding the approval of agents that prevent and treat precancerous lesions when the link between these lesions and cancer is shown. The statement is being released in conjunction with AACR's first-ever annual Frontiers in Cancer Prevention Research meeting, which has attracted nearly 1,000 researchers from across the globe.

"Our call for action urges researchers in academia, pharmaceutical companies and government to accelerate the development of chemopreventive agents," said Margaret Foti, Ph.D., Chief Executive Officer of AACR.

The AACR contends that the FDA should approve agents targeted to precancer, much as it has approved drugs to prevent other diseases. For example, the field of cardiovascular medicine was revolutionized when the FDA began to approve drugs such as lipid lowering agents to reduce heart attack risk, as opposed to directly preventing heart attacks directly.

"The AACR believes that reducing precancers lowers cancer risk, and that the FDA should take a similar stance regarding the approval of drugs for this condition," added Dr. Foti. AACR believes the link between some precancers and invasive cancers particularly in certain high-risk populations is so clear that drug developers should only be required to prove their proposed medicines are safe and effective in treating or preventing the evolution of precancer to cancer.

Aside from surgery, doctors now have limited options to treat precancers. Currently, only five agents have been approved by the FDA to combat specific precancers in patients with high-risk of developing cancers: topical 5-FU for actinic kerotoses, a precancer of the skin; topical diclofenic, also for actinic kerotoses; intravescial BCG, for bladder cancer; tamoxifen, for ductal carcinoma that leads to invasive breast cancer;

Contact: Aimee Frank
American Association for Cancer Research

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