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FDA approves raloxifene for breast cancer prevention
Drug indicated for use in postmenopausal women at high risk for invasive breast cancer or with osteoporosis.
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The FDA has approved raloxifene for the prevention of invasive breast cancer, making it the second drug available for breast cancer prevention.
Raloxifene (Evista, Eli Lilly) is indicated for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.
Raloxifene is a selective estrogen receptor modulator. On July 24, 2007, the FDA’s Oncology Drugs Advisory Committee recommended approval for raloxifene to reduce the risk of breast cancer among postmenopausal women with osteoporosis and among postmenopausal women at high risk for breast cancer.
In 1997, the FDA approved raloxifene for the prevention of osteoporosis in postmenopausal women and for the treatment of postmenopausal women with osteoporosis in 1999.
The FDA based this latest approval of raloxifene on a data package that included multiple trials assessing three different populations of postmenopausal women.
The Raloxifene Use for The Heart (RUTH) trial looked at postmenopausal women with known or increased risk for coronary disease. Raloxifene significantly reduced the risk for invasive breast cancer in postmenopausal women by 44% with an absolute risk reduction of 0.6%.
The Multiple Outcomes of Raloxifene Evaluation (MORE) and Continuing Outcomes Relevant to Evista (CORE) trials evaluated postmenopausal women with osteoporosis. Both four-year trials showed that raloxifene reduced the risk for invasive breast cancer in women. In MORE, the reduction was 71% with an absolute risk reduction of 1.1%, while in CORE it was 56% with an absolute risk reduction of 1%.
Raloxifene can cause serious adverse events including blood clots in the legs and lungs and death due to stroke. Women with current or prior blood clots in the legs, lungs or eyes should not take raloxifene.
Other potential adverse events include hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain and sweating.
Raloxifene should not be taken by premenopausal women and women who are or may become pregnant.
In addition, raloxifene should not be taken with cholestyramine or estrogens.
“Because raloxifene can cause serious adverse events, the benefits and risks of taking raloxifene should be carefully evaluated for each individual woman. Women should talk with their health care provider about whether the drug is right for them,” Steven Galson, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.