FDA Panel OKs Evista for Breast Cancer
Experts Recommend the Osteoporosis Drug for Use in Preventing Breast Cancer
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An FDA analysis of the three studies was inconclusive as to whether Evista's potential benefits outweighed its risks. Agency officials said they were troubled because Lilly had not submitted any data showing whether women who take Evista actually live longer than those who don't.
"It is uncertain if the balance of benefits and risk factors for women at high risk is favorable because the magnitude of benefits is unknown," says Patricia Cortazar, MD, an FDA safety official.
Several breast cancer advocacy groups opposed the approval. Carolina Hinestrosa, executive vice president of the Breast Cancer Coalition, says the government should boost efforts to find causes of breast cancer rather than approving drugs with relatively small benefits.
"Considering that most women will not develop breast cancer in their lifetimes ... taking raloxifene and tamoxifen as a risk reduction measure will be unnecessary for most," she says.
Some panelists urged the FDA to restrict the drug's marketing, particularly to keep it out of the hands of women at risk for cardiovascular disease. One panelist even suggested issuing a "black box" warning for Evista.
"There should be a strong effort to limit potential harm," says Curt D. Furburg, MD, a Wake Forest University professor of public health who voted to approve the new use for Evista.
Lilly paid $36 million in fines in 2005 after pleading guilty to illegally promoting Evista as a cancer-fighting drug. Critics said approving the new use for the drug would clear the way for the company to promote the drug with direct-to-consumer advertising.
Gwen Krivi, PhD, vice president of Lilly Research Laboratories, says the company will "continue working with the FDA to make this important option a reality for patients."
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