The FDA has approved Evista (raloxifene hydrochloride) 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 only the second drug approved to reduce the risk of 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. “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.” 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.