FDA Panel OKs Evista To Fight Breast Cancer

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evista.jpgAn FDA advisory committee this afternoon voted 8 to 6 to endorse Evista’s approval for reducing the risk of invasive breast cancer in post-menopausal women with osteoporosis, and also voted 10 to 4 to recommend the med for lowering the chance of getting breast cancer in post-menopausal women at high risk for the disease. The FDA will make a final decision but usually follows panel recommendations; Lilly says the FDA was expected to rule in September.

The drugmaker currently sells Evista treating and preventing osteoporosis, but wants approval to promote the med to prevent breast cancer. Panel member Dr. Antonio Grillo-Lopez, a retired oncologist, said Evista “shows at least similar efficacy and perhaps a better safety profile” than tamoxifen, the only medicine now approved for breast cancer prevention, according to Reuters.

Lilly said Evista has effects similar to those of the hormone estrogen in the bone, which helps fight osteoporosis, but blocks estrogen in breast tissue. The company presented studies of 37,000 women that compared Evista to a placebo or tamoxifen.

Studies found Evista cut the risk of developing breast cancer that needs estrogen to grow when tested against a placebo, FDA reviewers said. Taking Evista did not appear to reduce the chances of breast cancers that do not need estrogen to advance, the FDA staff analysis said.

One study showed 862 women must be treated with Evista for a year to prevent an invasive breast cancer in one of them, FDA reviewers said. They said Evista’s benefits should be weighed against serious risks, such as blood clots or possibly dying from a stroke.

“The number of patients needed to treat for some benefit is astounding,” said Dr. Ronald Richardson, a panel member and medical oncology consultant at the Mayo Clinic.

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