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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
September 14, 2007

Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves New Uses for Evista
Drug Reduces Risk of Invasive Breast Cancer in Postmenopausal Women

The U.S. Food and Drug Administration today approved Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Evista is only the second drug approved to reduce the risk of breast cancer.

Evista is commonly referred to as a selective estrogen receptor modulator (SERM). In reducing the risk of invasive breast cancer, SERMs may act by blocking estrogen receptors in the breast.

"Today's action provides an important new option for women at heightened risk of breast cancer," said Steven Galson, M.D., M.P.H., director, FDA's Center for Drug Evaluation and Research. "Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman. Women should talk with their health care provider about whether the drug is right for them."

On July 24, 2007, FDA's Oncology Drugs Advisory Committee recommended approval of Evista for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in women at high risk for breast cancer.

In 1997, FDA approved Evista for the prevention of osteoporosis in postmenopausal women and, in 1999, for the treatment of postmenopausal women with osteoporosis.

Breast cancer is the second leading cause of cancer death in American women and accounts for 26 percent of all cancers among women. An estimated 178,480 new cases of invasive breast cancer are expected to occur among women in the United States during 2007. Invasive breast cancer develops when abnormal cells spread into the surrounding breast tissue.

Three clinical trials in 15,234 postmenopausal women comparing Evista to placebo (no drug) demonstrated that Evista reduces the risk of invasive breast cancer by 44 to 71 percent. A fourth clinical trial in 19,747 postmenopausal women at high risk for developing breast cancer compared Evista to tamoxifen. In this trial, the risk of developing invasive breast cancer was similar for the two treatments. The clinical trials were conducted over the last 10 years.

Evista can cause serious side effects 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 Evista. Other potential side effects include hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating. Evista should not be taken by premenopausal women and women who are or may become pregnant because it may cause harm to the unborn baby. In addition, Evista should not be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens.

The benefits and risks of taking Evista should be carefully weighed in each individual woman. Evista does not completely prevent breast cancer. Breast examinations and mammograms should be done before starting Evista and regularly thereafter.

The product is manufactured by Eli Lilly and Company, Indianapolis, Ind.

For more information, visit: http://www.hhs.gov/breastcancer/

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