FDA okays osteoporosis drug Evista to reduce breast cancer risk

19 September, 2007

The United States Food and Drug Administration (FDA) has approved the use of the osteoporosis drug Evista to prevent invasive breast cancer in certain groups of high-risk women.

The FDA approval covers post-menopausal women with osteoporosis and post-menopausal women at high risk of invasive breast cancer, according to Eli Lilly and Company, manufacturer of Evista.

Steven Galson, director of FDA’s Center for Drug Evaluation and Research said in a statement that, “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.”

For the first time, post-menopausal women with osteoporosis will have one treatment option that can help address two leading health concerns, osteoporosis and invasive breast cancer, according to Gwen Krivi, vice-president of Lilly Research Laboratories. Further, post-menopausal women at high risk for invasive breast cancer will have an alternative therapy for invasive breast cancer risk reduction.

On July 24, 2007, the FDA’s Oncologic Drugs Advisory Committee had voted 8 to 6 to recommended approval of Evista (raloxifene) for post-menopausal women with osteoporosis, and voted 10 to 4 to recommended it for post-menopausal women at high risk for breast cancer.

The FDA approval of Evista, which studies have shown can produce potentially dangerous side effects such as blood clots and stroke, would give women a valuable option in fighting breast cancer, a member of the FDA’s Oncologic Drugs Advisory Committee had said following the July 24 vote.

While Evista has been shown to reduce the risk of breast cancer among post-menopausal women with osteoporosis, and postmenopausal women at high risk for breast cancer, it also increases their risks for blood clots and stroke.

In the raloxifene trials – which included over 10,000 post-menopausal women – researchers found that, compared with a placebo, Evista had no significant effect on the risk of first-time coronary events.

However, it reduced the risk of invasive breast cancer by 44%, that is, about 1.2 fewer cases of cancer per 1,000 women treated with raloxifene a year.

While the study showed no significant difference in deaths from any cause, or total deaths from stroke, women in the raloxifene group did have a 55% increased risk of fatal stroke (0.7 excess fatal strokes per 1,000 women treated per year) and a 44% increased risk of blood clots (1.2 more cases per women treated per year), according to a report published in the July 2006 issue of the New England Journal of Medicine.

In the ‘Study of Tamoxifen and Raloxifene’ trial published in June 2006, almost 20,000 post-menopausal 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% – from 8 cases per 1,000 women per year to about 4 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.