Gwen Krivi, vice president of Lilly research laboratories, said: “The FDA’s decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns – osteoporosis and invasive breast cancer. Further, postmenopausal women at high risk for invasive breast cancer will have an alternative therapy for invasive breast cancer risk reduction.”
Evista, a selective estrogen receptor modulator, is already approved for the prevention and treatment of osteoporosis in postmenopausal women. In July, the oncologic drugs advisory committee (ODAC) to the FDA voted to recommend approval for the new uses. The decision and the positive recommendation from ODAC were based on data submitted in November 2006 in a new drug application (NDA), evaluating clinical results from approximately 37,000 postmenopausal women that spanned nearly 10 years.
Dr Lawrence Wickerham, associate chairman of the national surgical adjuvant breast and bowel project, and associate professor of human oncology at Drexel university school of medicine, said: “Thousands of women each year are diagnosed with invasive breast cancer. Evista approval for these new uses gives postmenopausal women at risk for this disease an important new treatment option that allows them to take a proactive approach to reducing their risk.”