The U.S. Food and Drug Administration today 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.
Breast cancer is the second leading cause of cancer death in
American women and accounts for 26 percent of all cancers among
women. An estimated 178,480 new cases of invasive breast cancer are
expected to occur among women in the United States during 2007.
Invasive breast cancer develops when abnormal cells spread into the
surrounding breast tissue.