FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk

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"The drug has been demonstrated to have benefit in preventing breast cancer in women at increased risk," Lichtenfeld said following the July advisory panel vote. "The drug should be approved. That would then give us two options, and Evista may have a better safety profile than tamoxifen," he said.

In the STAR (Study of Tamoxifen and Raloxifene) trial published in June 2006, almost 20,000 postmenopausal women at increased risk for breast cancer took either tamoxifen or Evista daily for five years. Tamoxifen is the only drug approved for reducing breast cancer risk.

That trial found that both drugs reduced the risk of breast cancer by about 50 percent -- from eight cases per 1,000 women per year to about four per 1,000 women per year.

However, Evista was not as effective in preventing non-invasive breast cancers as tamoxifen, according to a report, which appeared in the Journal of the American Medical Association.

"Both Evista and tamoxifen have risks," Lichtenfeld acknowledged. "But Evista has been used widely for the treatment of osteoporosis, so physicians are comfortable with that. While this is not a perfect answer to the increased risk of breast cancer, it is the best answer we have right now."

In 2005, Eli Lilly pleaded guilty and paid a $36 million fine for illegally promoting Evista to reduce the risk of breast cancer, a violation of the Food, Drug, and Cosmetic Act.

More information

For more information on breast cancer, visit the American Cancer Society.