Starring role for Lilly's Evista
Eli Lilly and Co says the latest results of the Study of Tamoxifen and Raloxifene (STAR) trial, announced by the National Surgical Adjuvant Breast and Bowel Project (NSABP0), signals good news for Evista (raloxifene HCl).
Eli Lilly and Co says the latest results of the Study of Tamoxifen and Raloxifene (STAR) trial, announced by the National Surgical Adjuvant Breast and Bowel Project (NSABP0), signals good news for Evista (raloxifene HCl).
Funded by the National Cancer Institute and conducted by researchers with the NSABP, the trial has produced data that - coupled with data from the Raloxifene Use for the Heart (RUTH) trial - Lilly intends to use for a submission to the US FDA in support of an indication for Evista for the reduction of invasive breast cancer risk in postmenopausal women.
Evista is currently marketed in the US for the prevention and treatment of osteoporosis in postmenopausal women. Raloxifene has not been approved by the FDA for reducing the risk of cardiovascular disease or invasive breast cancer.
Lilly recently has already announced preliminary results from RUTH. Final results from that study are being analysed and will be presented later this year.
RUTH and STAR, combined with data from Multiple Outcomes of Raloxifene Evaluation (MORE) and Continuing Outcomes Relevant to Evista (CORE) would be included in a potential supplemental new drug application filing package.