The U.S. Food and Drug Administration has approved Evista, an osteoporosis drug produced by Eli Lilly,  for a new use to reduce the risk of invasive breast cancer.

"The FDA's decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns-osteoporosis and invasive breast cancer," said Gwen Krivi, Ph.D., vice president of Lilly Research  Laboratories. "Further, postmenopausal women at high risk for invasive breast cancer will have an alternative therapy for invasive breast cancer risk reduction."

In July Evista, which is a selective estrogen receptor modulator or SERM, was approved by the FDA’s Oncologic Drugs Advisory Committee for the prevention and treatment of osteoporosis in postmenopausal women.

Evista is reducing the risk of invasive breast cancer by blocking estrogen receptors in the breast. Eli Lilly presented the results of three clinical trials that proved that that Evista reduces the risk of invasive breast cancer by 44 percent to 71 percent. During the clinical trials that spanned nearly 10 years approximately 37,000 postmenopausal women were tested.

The American Cancer Society estimates that approximately 180,000 women are diagnosed with invasive breast cancer each year and about one in eight women will develop invasive breast cancer at some time in their lives.

"Thousands of women each year are diagnosed with invasive breast cancer," said Dr. Lawrence Wickerham, M.D., associate chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP), and associate professor of human oncology at Drexel University School of Medicine. "Today's approval of EVISTA for these new uses gives postmenopausal women at risk for this disease an important new treatment option that allows them to take a proactive approach to reducing their risk."

The FDA warned that Evista should not be taken by premenopausal women and women who are or may become pregnant, because it may cause harm to the fetus.

Also the drug's label would now include a boxed warning stressing that women with a history of blood clots should not take Evista and that women at risk for stroke should consult a physician before using the drug.