Eli Lilly and Co announced that the Oncologic Drugs Advisory Committee of the US Food and Drug Administration (FDA) voted to recommend approval of its osteoporosis drug raloxifene(Drug information on raloxifene) (Evista) for a new use, to reduce invasive breast cancer risk in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer. The Advisory Committee's vote for each population was 8 to 6 and 10 to 4, respectively. Advisory Committee recommendations to the FDA are nonbinding.

Raloxifene is a selective estrogen-receptor modulator, or SERM, that is currently indicated for the prevention and treatment of osteoporosis in postmenopausal women. Last November, Lilly submitted a new drug application (NDA) to the FDA requesting that it evaluate the agent for this new use based on data from approximately 37,000 postmenopausal women that spanned nearly 10 years.

"Today is an especially good day for postmenopausal women," said Gwen Krivi, PhD, vice president of Lilly Research Laboratories. "If approved, Evista would be the first and only therapy available to address two leading health issues for postmenopausal women—osteoporosis and breast cancer. Following today's vote, our intention is to continue working with the FDA to make this important option a reality for patients."

Data From Three Trials

The Advisory Committee reviewed four studies submitted to the FDA in the NDA package, representing data from three different populations of postmenopausal women:

• Postmenopausal women at increased risk for breast cancer in the Study of Tamoxifen(Drug information on tamoxifen) and Raloxifene (STAR) trial, sponsored by the National Cancer Institute (NCI) and coordinated by the National Surgical Adjuvant Breast and Bowel Project (NSABP)

• Postmenopausal women with known or at increased risk for coronary disease in the Raloxifene Use for The Heart (RUTH) trial

• Postmenopausal women with osteoporosis in the Multiple Outcomes of Raloxifene Evaluation (MORE) and Continuing Outcomes Relevant to Evista (CORE) trials.