FDA Approves Eli Lilly's Osteoporosis Drug Evista To Prevent Breast Cancer

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Osteoporosis Drug Evista

An FDA advisory panel on Tuesday voted in favor of recommending that Eli Lilly'sbone-strengthening drug raloxifene, sold under the brand-name Evista,be approved to reduce the risk of breast cancer in some women, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 7/25).

FDAin 1997 approved Evista to help prevent osteoporosis and in 1999approved it to treat the disease. Tamoxifen, which blocks theproduction of estrogen, is the only FDA-approved drug for reducingbreast cancer risk, but it increases risk for uterine cancer and bloodclots. Raloxifene, which also blocks estrogen production, has beenshown to be as effective as tamoxifen at reducing breast cancer risk, though it increases risk of hot flashes and other menopause-related symptoms.

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Indocuments released Friday, FDA said Evista lowers the risk of invasivebreast cancer in some patients. The agency also said it would ask thepanel to weigh the drug's benefits against serious side effects, suchas deep vein thrombosis, pulmonary embolism and possible fatal stroke.Evista proved effective in reducing the risk of breast cancer inpostmenopausal women whose cancer is fueled by estrogen; however, thereseemed to be no decrease in risk among patients whose cancer did notneed estrogen to grow, FDA reviewers said in the documents. They alsosaid that studies have provided less evidence for the proposed use toreduce the risk of developing invasive breast cancer in postmenopausalwomen at high risk of developing the disease (Kaiser Daily Women's Health Policy Report, 7/23).

TheFDA panel on Tuesday voted 8-6 to allow Lilly to state on Evista'slabel that it reduces breast cancer risk "in postmenopausal women withosteoporosis." The panel also voted 10-4 to allow the label to statethat Evista reduces the "risk of invasive breast cancer in women athigh risk for breast cancer" (Wall Street Journal, 7/25).Antonio Grillo-Lopez, a panel member and retired oncologist, saidEvista "shows at least similar efficacy and perhaps a better safetyprofile" than tamoxifen.

Reviewers on the panel also said useof the drug should be weighed against potential risks such as bloodclots and fatal stroke. One study on the drug found that 862 women mustbe treated for Evista for one year to prevent invasive breast cancer inone of the women, according to reviewers. "The number of patientsneeded to treat for some benefit is astounding," Ronald Richardson, apanel member and medical oncology consultant for the Mayo Clinic, said (Richwine, Reuters, 7/24).

"Today is an especially good day for postmenopausal women," Gwen Krivi, vice president of Lilly Research Laboratories,said, adding, "If approved, Evista would be the first and only therapyavailable to address two leading health issues for postmenopausal women-- osteoporosis and breast cancer" (Eli Lilly release, 7/24). The company said FDA is expected to rule on the drug in September (Reuters, 7/24). FDA generally follows the recommendations of the panel but is not required to do so, the AP/Forbes reports (AP/Forbes, 7/24).
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Reprinted with permission fromkaisernetwork.org.You can view the entire KaiserDaily Women's Health Policy Report, search thearchives, and sign up for email delivery at kaisernetwork.org/email. The Kaiser Daily Women's Health Policy Report is published forkaisernetwork.org,a free service of The Henry J. Kaiser Family Foundation.

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