Eli Lilly and Company (NYSE: LLY) announced today that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration’s Division of Drug Oncology Products (DDOP) 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.
“If approved, EVISTA would be the only therapy to address two leading health issues for postmenopausal women — osteoporosis and breast cancer,” said Gwen Krivi, Ph.D., vice president of Lilly Research Laboratories. “We believe this potential new indication for EVISTA would provide a tremendous opportunity for postmenopausal women with these health issues.”
The filing, submitted in November 2006, includes data from four clinical trials — two pivotal trials and two supportive trials, representing data from three different patient populations:
* Postmenopausal women at increased risk for invasive breast cancer in the Study of Tamoxifen and Raloxifene (STAR) trial
* 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.
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 (NSABP), were published in the Journal of the American Medical Association on June 28, 2006. Results from the RUTH trial were published in the New England Journal of Medicine on June 13, 2006. The NDA includes data from more patients than any other submission in Lilly’s history — approximately 37,000 postmenopausal women from four studies that have spanned nearly 10 years.
The American Cancer Society estimates approximately 200,000 women are diagnosed with invasive breast cancer each year.(i) While the exact causes of breast cancer are unknown, there are many risk factors associated with its development, including age, family or personal history of breast cancer, genetics, race and lifestyle factors. Increased age is a particularly important risk factor, as the majority of breast cancer cases occur in women over age 50.(ii) It is important for postmenopausal women to speak with their doctor or healthcare professional about their personal risk for breast cancer.