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OVARIAN CANCER DRUG APPROVED

 WASHINGTON, Dec. 29 /PRNewswire/ -- The Food and Drug Administration today announced the approval of Taxol for ovarian cancer that has failed to respond to other chemotherapy, or has progressed afterward.
 HHS Secretary Louis W. Sullivan, M.D., said: "This is an important, second-stage use because, although most patients respond to chemotherapy initially, the disease often recurs. Ovarian cancer is diagnosed in 21,000 women and claims 13,000 lives each year. I'm pleased to see the Bush administration's recent reforms pay off in expediting this key drug review, which was among the most complex FDA has faced."
 Dr. James Mason, HHS assistant secretary for health and head of the Public Health Service, said, "Taxol's quick approval by FDA in a record five months -- with the cooperation of the National Cancer Institute's network of investigators -- makes a good conclusion to a year of increased emphasis on women's health at the National Institutes of Health, FDA and throughout the Public Health Service agencies."
 "We are committed to expediting the review of drugs for serious and life-threatening diseases like cancer and AIDS," FDA Commissioner David A. Kessler, M.D., said. "Although it is not a cure, Taxol clearly will make a difference in the lives of many women with ovarian cancer."
 Although Taxol is derived from the bark of the Pacific yew tree, adequate supplies of the drug are expected to be available, FDA said. Researchers are also working on alternative sources of the drug.
 Michael A. Friedman, M.D., associate director of NCI's therapy evaluation program, said, "The Department of Agriculture's Forest Service, Interior's Bureau of Land Management and Bristol-Myers Squibb Co. have done outstanding work in procuring adequate supplies of Taxol."
 Also known as paclitaxel, the drug was tested in clinical trials involving 200 women in the United States. The drug was further tested in more than 2,000 patients in treatment referral center studies. It was found affective in reducing tumor size by at least on half in 20 to 30 percent of patients, with an average survival rate of nine months.
 These data were reviewed jointly by officials from FDA and the Health Protection Branch of the Canadian Department of Health and Welfare. Bristol-Myers Squibb of Wallingford, Conn., will market the drug.
 Taxol may be particularly useful for patients with ovarian cancer that has progressed despite treatment with standard chemotherapy regimens and is resistant to treatment with platinum-based drugs such as cis-platin. Platinum-based drug regimens have been the most effective standard agents available for treating ovarian cancer.
 While Taxol is toxic, its risks are outweighed by potential benefits for patients with advanced ovarian cancer. Taxol's side effects are similar to those of other cancer therapies, including hair loss, decrease in white blood cells -- which may increase susceptibility to infections -- and numbness of the fingers and toes.
 Although FDA's approval of Taxol is limited to its use in refractory ovarian cancer, patients with many other forms of cancer are receiving the drug in clinical trials.
 FDA and NIH, including NCI, are agencies of the U.S. Public Health Service within HHS. A Public Health Service Action Plan for Women's Health was set in motion last year to emphasize work on such conditions as breast cancer, reproductive disorders and diseases, substance abuse in women and osteoporosis.
 -0- 12/29/92
 /NOTE: Attention TV broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Susan Cruzan of the Food and Drug Administration, 301-443-3285 or, after hours, 301-926-7081/


CO: Food and Drug Administration; National Cancer Institute;
 Bristol-Myers Squibb Co. ST: District of Columbia IN: MTC SU:


KD -- DC009 -- 0352 12/29/92 13:46 EST
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Date:Dec 29, 1992
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