ELI LILLY SUBMITS NDA FOR EVISTA IN BREAST CANCER

Eli Lilly has submitted a new drug application (NDA) to the FDA for Evista (raloxifene HCl) for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer. Evista is currently indicated for the treatment and prevention of osteoporosis in postmenopausal women.

The application includes data from four clinical trials that spanned 10 years and included approximately 37,000 postmenopausal women. Results from the STAR trial, which was funded by the National Cancer Institute (NCI) and conducted by researchers with the National Surgical Adjuvant Breast and Bowel Project, were published in The Journal of the American Medical Association on in June. Results from the RUTH trial were also published in the New England Journal of Medicine in June.

Evista is neither an estrogen nor a hormone, but rather a selective estrogen receptor modulator. It helps build bone without negatively affecting the breast or uterus. The drug prevents and treats osteoporosis by actually helping make bones stronger and less likely to break.