FDA Advisory Committee Recommends Approval of Evista® for Cancer Risk Reduction

Cancer Connect

A committee that advises the U.S. Food and Drug Administration (FDA) recently recommended the approval of the osteoporosis drug Evista® (raloxifene) for a new use: reducing the risk of breast cancer in specific groups of postmenopausal women. The FDA is not required to follow the recommendations of the advisory committee, but it will consider them.

For women at high risk of breast cancer, treatment with tamoxifen-a selective estrogen receptor modulator (SERM)-has been shown to reduce the risk of breast cancer. Possible side effects of tamoxifen include an increased risk of endometrial cancer (cancer of the uterine lining) and blood clots. Researchers have continued to explore other approaches to breast cancer risk reduction.

Evista is a selective estrogen receptor modulator that is approved for the prevention and treatment of osteoporosis in postmenopausal women. In addition to its effects on bone, recent studies suggest that that Evista is as effective as tamoxifen in reducing the risk of invasive breast cancer.

A study known as the STAR trial (The NSABP Study of Tamoxifen and Raloxifene [STAR] P-2 Trial), directly compared Evista to tamoxifen for the prevention of breast cancer in postmenopausal women who were considered at high risk of developing the disease. A womans risk of breast cancer was estimated based on family history of breast cancer, personal medical history, age, age at first menstrual period, and age at first live birth. The trial enrolled over 19,000 women.

Results of the STAR trial indicated that Evista was as effective as tamoxifen in reducing the risk of invasive breast cancer, though possibly less effective at reducing the risk of noninvasive breast cancer.[[1]](http://news.cancerconnect.com/fda-advisory-committee-recommends-approval-of-evista-for-breast-cancer-risk-reduction/#_edn1 "_ednref1") Women treated with Evista had a lower risk of blood clots and cataracts than women treated with tamoxifen.

Although the risk of blood clots appears to be lower with Evista than with tamoxifen, risk is still likely to be higher than among women who receive no treatment at all. A study of women with heart disease or at high risk of heart disease reported that compared to treatment with a placebo, treatment with Evista increased the risk of blood clots and fatal stroke.[[2]](http://news.cancerconnect.com/fda-advisory-committee-recommends-approval-of-evista-for-breast-cancer-risk-reduction/#_edn2 "_ednref2")

After consideration of these and other studies, the Oncologic Drugs Advisory Committee of the FDA recommended that the FDA approve Evista for reducing the risk of invasive breast cancer in two groups of postmenopausal women: postmenopausal women with osteoporosis and postmenopausal women at high risk of breast cancer.[[3]](http://news.cancerconnect.com/fda-advisory-committee-recommends-approval-of-evista-for-breast-cancer-risk-reduction/#_edn3 "_ednref3")

The FDA will consider the Committees recommendations when making its decision. If approved for this use, Evista will offer an additional option for breast cancer risk reduction in selected groups of postmenopausal women.

References:

[[1]](http://news.cancerconnect.com/fda-advisory-committee-recommends-approval-of-evista-for-breast-cancer-risk-reduction/#_ednref1 "_edn1") Vogel VG, Costantino JP, Wickerham DL et al. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial. JAMA. 2006;295:2727-41.

[[2]](http://news.cancerconnect.com/fda-advisory-committee-recommends-approval-of-evista-for-breast-cancer-risk-reduction/#_ednref2 "_edn2") Barrett-Connor E, Mosca L, Collins P, et al. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. New EnglandJournal of Medicine. 2006; 355: 125-137.

[[3]](http://news.cancerconnect.com/fda-advisory-committee-recommends-approval-of-evista-for-breast-cancer-risk-reduction/#_ednref3 "_edn3") Eli Lilly and Company. FDA Advisory Committee Recommends Approval of EVISTA for the Reduction of Risk for Invasive Breast Cancer in Two Populations of Postmenopausal Women. July 24, 2007. Available at: http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=256148&print=yes (Accessed July 25, 2007).

Related News:Similar Quality of Life with Evista® and Nolvadex® for Prevention of Breast Cancer(10/23/2006)

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