FDA Advisory Panel To Consider Approving Eli Lilly's Osteoporosis Drug Evista To Be Used To Prevent Breast Cancer

Main Category: Breast Cancer
Also Included In: Women's Health / Gynecology;  Seniors / Aging;  Endocrinology
Article Date: 25 Jul 2007 - 6:00 PDT

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An FDA advisory panel on Tuesday will consider whether Eli Lilly's bone-strengthening drug raloxifene, sold under the brand-name Evista, should be approved to reduce the risk of breast cancer in some women, USA Today reports. FDA in 1997 approved Evista to help prevent osteoporosis and in 1999 approved it to treat the disease (Rubin, USA Today, 7/23).

Tamoxifen, which blocks the production of estrogen, is the only FDA-approved drug for reducing breast cancer risk, but it increases risk for uterine cancer and blood clots. Raloxifene, which also blocks estrogen production, has been shown to be as effective as tamoxifen at reducing breast cancer risk, but it increases risk of hot flashes and other menopause-related symptoms (Kaiser Daily Women's Health Policy Report, 6/20).

In documents released Friday, FDA said Evista lowers the risk of invasive breast cancer in some patients, and the agency will ask the panel to weigh the drug's benefits against serious side effects, such as deep vein thrombosis, pulmonary embolism and possible fatal stroke. Evista proved effective in reducing the risk of breast cancer in postmenopausal women whose cancer is fueled by estrogen; however, there seemed to be no decrease in risk in patients whose cancer did not need estrogen to grow, FDA reviewers said in the documents. They also said that the studies provided less evidence for the proposed use to reduce the risk of developing invasive breast cancer in postmenopausal women at high risk of developing the disease (Reuters, 7/20).

Cindy Pearson, executive director of the National Women's Health Network, said, "Approval (of Evista) allows advertising, and the advertising, almost by definition, is going to be misleading," adding, "It's going to imply that there's a bigger net benefit than we know to be true." Lilly spokesperson Gregory Clarke said, "There's a large, robust body of data that has to be looked at" (USA Today, 7/23).

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