ROCKVILLE, MarylandDespite the concerns of some members of the Oncologic Drugs Advisory Committee (ODAC) and the opposition of several advocacy groups, the panel recommended that the Food and Drug Administration approve two cancer-related indications for Evista (raloxifene), Eli Lilly's selective estrogen-receptor modulator (SERM).
By a vote of 8 to 6 with one abstention, ODAC supported marketing approval for the drug's use for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis, and by a 10-to-4 vote with one abstention, for reducing the risk of invasive breast cancer in postmenopausal women at high risk of breast cancer.
FDA previously approved Evista for the prevention and treatment of osteoporosis in postmenopausal women. The need for a separate breast cancer prevention indication for women with osteoporosis puzzled some committee members. "I don't understand, really, what is to be gained by the first indication," said Michael Link, MD, professor of pediatrics and chief of hematology/oncology at Stanford University School of Medicine.
"It's a very competitive environment," replied Richard Pazdur, MD, director of FDA's Office of Oncology Drug Products, a remark that drew a hearty laugh from the committee and audience.
The meeting was also punctuated by a rare rebuke to patient advocates from a member of the panel (see box), and questions about whether at-risk women will accept Evista as a preventive agent at a higher rate than they have tamoxifen.
The relatively low usage of of tamoxifen since FDA approved the drug for reducing the risk of breast cancer in high-risk women has generally been attributed to the concerns of women about the risks of endometrial cancer and thrombolic adverse events associated with its use.
RUTH, STAR, and MORE/CORE
To support its New Drug Application, Lilly presented data from three placebo-controlled trials and the active-control Study of Tamoxifen and Raloxifene (STAR) trial, which was conducted without a placebo arm. "The most important data supporting the proposed new indications come from the RUTH [Raloxifene Use for the Heart] and STAR trials," Dr. Pazdur told the committee members.