Eli Lilly and Company (NYSE: LLY) announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted to recommend approval of its osteoporosis drug EVISTA(R) (raloxifene HCl) 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 Committees’ vote for each population was 8 to 6 and 10 to 4, respectively. Advisory Committee recommendations to the FDA are non-binding.
EVISTA is a selective estrogen receptor modulator, or SERM (recently classified by the FDA as an estrogen agonist/antagonist). EVISTA 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 EVISTA 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, Ph.D., 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.”
The American Cancer Society estimates approximately 180,000 women are diagnosed with invasive breast cancer each year. While the exact causes of breast cancer are unknown, there are certain risk factors linked to the disease, including age, family history, personal history of breast cancer, genetics, race and lifestyle factors. Increased age is a particularly important risk factor, as nearly eight out of 10 breast cancers are found in postmenopausal women age 50 and older.
The Advisory Committee reviewed four studies submitted to the FDA in
the NDA package, representing data from three different populations of
* Postmenopausal women at increased risk for breast cancer in the Study of 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
Lilly will continue to work with the FDA as the agency moves toward action on the NDA submission.