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

Main Category: Breast Cancer
Also Included In: Bones / Orthopaedics;  Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology
Article Date: 19 Sep 2007 - 6:00 PST

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Eli Lilly on Friday announced that it has received FDA approval for its bone-strengthening drug raloxifene, sold under the brand-name Evista, to reduce the risk of breast cancer for postmenopausal women at high risk of the disease and postmenopausal women with osteoporosis, the Wall Street Journal reports (Wall Street Journal, 9/15).

FDA in 1997 approved Evista to help prevent osteoporosis and in 1999 approved it to treat the disease. Tamoxifen, which blocks the production of estrogen, is the only other 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, though it increases risk of hot flashes and other menopause-related symptoms.

In documents released in July, FDA said Evista lowers the risk of invasive breast cancer in some patients. The drug also 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 among patients whose cancer did not need estrogen to grow, FDA reviewers said in the documents. They also said that studies have provided less evidence for using the drug to reduce the risk of developing invasive breast cancer in postmenopausal women at high risk of developing the disease (Kaiser Daily Women's Health Policy Report, 7/25).

In its approval announcement Friday, FDA noted that Evista can cause blood clots in the legs, leg cramps, swelling of the legs and feet, hot flashes, flu-like symptoms, joint pain, sweating and an increased risk of death due to stroke. FDA said that women with current or prior blood clots in the legs, lungs or eyes should not use Evista, adding that premenopausal women and women who are or might become pregnant should not take the drug. Evista should not be taken with cholestyramine, a drug used to lower cholesterol levels, or estrogens, the agency said (Fahy, Pittsburgh Post-Gazette, 9/15). According to the Journal, the drug will carry a boxed warning saying that a study found that although Evista users did not have a higher incidence of stroke, users who had had a stroke had a higher mortality rate (Wall Street Journal, 9/15).

Comments
The expanded use of Evista "provides an important new option for women at heightened risk of breast cancer," Steven Galson, director of FDA's Center for Drug Evaluation and Research, said, adding, "Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated." Lawrence Wickerham, associate chair of the National Surgical Adjuvant Breast and Bowel Project, said the announcement is "extraordinarily good news for postmenopausal women at increased risk for future breast cancer." He added that if enough women take the drug, "we may see a further decline in breast cancers around the country and the world" (Pittsburgh Post-Gazette, 9/15).

Sandhya Pruthi, director of breast diagnostics at the Mayo Clinic, said she thinks "a lot of patients will start to ask" for Evista, in part because it "can help the bones and the breasts" (Sherman, Reuters, 9/14). Tony Butler, an analyst for Lehman Brothers, said he does not think Evista will attract many new patients who already do not have osteoporosis. "I think it's hard to say you might be at risk for breast cancer, take this," Butler said, adding, "I think it's easier to say you need this for osteoporosis and you've got a history of breast cancer" (AP/International Herald Tribune, 9/14).

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