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FDA Approves Evista For Reducing Breast Cancer Risk

New option for women at high risk of breast cancer

September 14, 2007

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Evista, an Eli Lily drug used in estrogen treatment, has a new approved function.

The U.S. Food and Drug Administration has approved Evista as a means 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 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.

But he added a word of caution.

“Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman,” he said. “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 demonstrated that Evista reduces the risk of invasive breast cancer by 44 to 71 percent, according to the agency.

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.

But doctors will likely look closely at the benefit-to-risk ratio for their patients. 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, the FDA advises. 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.

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