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Panel backs osteoporosis drug for reducing breast ca risk.

A Food and Drug Administration advisory panel has recommended that raloxifene be approved to reduce the risk of invasive breast cancer in postmenopausal women who have osteoporosis or who are at high risk of breast cancer.

The Oncologic Drugs Advisory Committee recommended approval of raloxifene, a selective estrogen receptor modulator. Raloxifene was originally approved by the FDA in 1997 to prevent and treat osteoporosis in postmenopausal women. According to a statement from Eli Lilly and Co., which markets raloxifene as Evista, more than 52 million prescriptions for the drug have been filled since its approval.

Using data from 37,000 postmenopausal women over a 10-year period, Eli Lilly submitted a new drug application to the FDA in 2006 to extend the drug's use to reducing breast cancer risk in this same group of patients. If approved, Evista would be the "first and only therapy available to address two leading health issues for postmenopausal women--osteoporosis and breast cancer," Gwen Krivi, Ph.D., vice president of Lilly Research Laboratories, said in a written statement.

Although the committee voted to approve the indication for breast cancer risk reduction in postmenopausal women with osteoporosis (8 to 6) and in postmenopausal women at high risk for breast cancer (10 to 4), the FDA is not obligated to approve these new indications.

In preparing for its decision, the committee reviewed four large studies also submitted in the application: The Study of Tamoxifen and Raloxifene (STAR) trial; Raloxifene Use for the Heart (RUTH) trial; Multiple Outcomes of Raloxifene Evaluation (MORE); and the Continuing Outcomes Relevant to Evista (CORE) trials.

Dr. Wulf Utian, executive director of the North American Menopause Society, said in an interview that the committee's decision was a positive step that could increase the number of products available as potential reducers of breast cancer. Tamoxifen is now the only other drug indicated for the reduction of breast cancer incidence in women at high risk for the disease.

The committee's recommendation to approve raloxifene for the two new indications comes at a good time, as tamoxifen sales and use have been "disappointing" because of various side effects, said Dr. Utian, who said he serves as a consultant to various pharmaceutical companies, including Eli Lilly.

When it was first published in the New England Journal of Medicine last year, the RUTH study raised some concerns about risk of death from stroke and the incidence of blood clots associated with raloxifene use (N. Engl. J. Med. 2006;355:125-37). Various experts questioned this stroke risk, including Marcia Stefanick, Ph.D., from Stanford (Calif.) University, who wrote an accompanying editorial about the study (N. Engl. J. Med. 2006;355:190-2).

Dr. Utian said the prevalence of both stroke and venous thromboembolism increases with age. He emphasized, however, that most women who would start taking tamoxifen or raloxifene for prevention would do so at a younger age, when the prevalence and absolute risk for these adverse events would be lower.


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Title Annotation:NEWS FROM THE FDA
Author:Bullock, Lorinda
Publication:Clinical Psychiatry News
Date:Sep 1, 2007
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