Lilly Drug Cuts Some Breast Cancer Risk: FDA Staff

BOSTON (Reuters) Jul 20 - Eli Lilly & Co.'s osteoporosis drug Evista reduces the risk of breast cancer in some patients, but at a cost of an increased risk of serious side effects, U.S. regulatory reviewers said in documents released on Friday.
Food and Drug Administration staff said Evista reduces the risk of invasive breast cancer in certain patients. But they said they will ask an advisory panel that meets Tuesday to weigh the benefit against serious risks, such as deep vein thrombosis, pulmonary embolism and possibly stroke death.
Evista is already approved to treat osteoporosis in women past menopause. The company is seeking approval to promote the drug for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer.
Studies showed Evista cut the risk of breast cancer in postmenopausal women whose cancer needs the hormone estrogen to grow. There appeared to be no reduction in risk in patients whose cancers do not need estrogen to grow, the reviewers said.
Studies provide less support for the proposed new use to reduce the chances of invasive breast cancer in postmenopausal women at high risk of developing breast cancer, the reviewers said. A trial known as STAR compared Evista to a drug called tamoxifen in postmenopausal women with a high risk of developing invasive breast cancer.
Reviewers found Evista was not better than tamoxifen.