FDA Panel OKs Evista for Breast Cancer
Experts Recommend the Osteoporosis Drug for Use in Preventing Breast Cancer
WebMD News Archive
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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
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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