An FDA advisory panel voted to back Eli Lilly's request to tell patients its osteoporosis treatment Evista (raloxifene) also helps reduce the risk of breast cancer, despite concerns over the drug's cardiovascular side effects.
The panel of outside experts voted 10-4 in favor of allowing Lilly to re-label Evista as cutting the “risk of invasive breast cancer in women at high risk for breast cancer.”
The panel also voted 8-6 to state Evista cuts breast cancer risk “in postmenopausal women with osteoporosis.”
The votes amount to an advisory panel recommendation to approve Lilly's request to re-label and market Evista as a breast cancer reduction drug.
The FDA often follows the advice of its advisory panels, although it is not required to do so.
The panel based its recommendations on the results of four studies presented by Lilly, including results of a large National Cancer Institute Study examining Evista and an older drug tamoxifen, in relation to preventing breast cancer.
The study of nearly 20,000 postmenopausal women showed that Evista and tamoxifen cut the risk of women developing breast cancer by nearly 50%.