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New Use of Breast Cancer Drug Femara Approved

FDA OKs Femara for Extended Breast Cancer Treatment

WebMD Health News

Nov. 1, 2004 -- A new use for the breast cancer drug Femara may offer an alternative for breast cancer survivors.

The FDA has approved the use of Femara for the extended treatment of early breast cancer in post-menopausal women who can no longer use the breast cancer drug, tamoxifen.

Tamoxifen is commonly used to help prevent breast cancer recurrence in post-menopausal women. But after five years of use the risks of the drug begin to exceed the benefits.

But by taking Femara after tamoxifen treatment has stopped, post-menopausal women can reduce their risk of breast cancer recurrence by 38%, new research shows.

Researchers say nearly one-third of women with estrogen-sensitive early breast cancer experience a cancer recurrence, and more than half of those recurrences occur more than five years after the initial cancer treatment.

Femara and tamoxifen are used to help block the effects of estrogen on breast cancers with estrogen receptors -- called estrogen receptor positive tumors, or ER positive.

The FDA based its approval on the results of a study of more than 5,100 post-menopausal women who had been treated for early breast cancer. The study showed that Femara reduced the risk of breast cancer coming back by 38% after two years of treatment compared with treatment with tamoxifen alone.

Femara had already been approved for treating breast cancer that has spread to other body parts. The study also showed that extended treatment with Femara after tamoxifen treatment reduced this risk of cancer recurrence in other parts of the body by 39%.

The breast cancer drug is taken as a once-daily pill. Side effects of Femara include hot flashes and joint and muscle pain. In addition, slightly more women taking Femara developed osteoporosis than those taking the placebo (7% vs. 6%), according to a statement from the drug's manufacturer, Novartis.

Femara should also not be taken by women who are pregnant or may become pregnant.

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