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

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An FDA advisory panel on Tuesday will consider whether Eli Lilly'sbone-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).

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Tamoxifen,which blocks the production of estrogen, is the only FDA-approved drugfor reducing breast cancer risk, but it increases risk for uterinecancer and blood clots. Raloxifene, which also blocks estrogenproduction, 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).

Indocuments released Friday, FDA said Evista lowers the risk of invasivebreast cancer in some patients, and the agency will ask the panel toweigh the drug's benefits against serious side effects, such as deepvein thrombosis, pulmonary embolism and possible fatal stroke. Evistaproved effective in reducing the risk of breast cancer inpostmenopausal women whose cancer is fueled by estrogen; however, thereseemed to be no decrease in risk in patients whose cancer did not needestrogen to grow, FDA reviewers said in the documents. They also saidthat the studies provided less evidence for the proposed use to reducethe risk of developing invasive breast cancer in postmenopausal womenat 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 goingto imply that there's a bigger net benefit than we know to be true."Lilly spokesperson Gregory Clarke said, "There's a large, robust bodyof data that has to be looked at" (USA Today, 7/23).
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