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Another Breast Cancer Drug OKd

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Newsday

Post- menopausal women have another option to treat early-stage breast cancer with the approval Wednesday of a drug aimed at stopping recurrences.

The U.S. Food and Drug Administration approved Femara, a medication manufactured by Novartis Pharmaceuticals and belonging to the class called aromatase inhibitors. Femara already is approved for post-menopausal women with advanced breast cancer.

Femara’s newly approved use comes as a team of Swiss researchers reports in today’s New England Journal of Medicine that the drug fared better than tamoxifen, the long-favored treatment for early-stage breast cancer for women of all ages.

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A mainstay for more than two decades, tamoxifen is the most widely prescribed anticancer drug and is credited with helping save the lives of millions of women. It is taken in pill form and generally prescribed for five years. But doctors reporting their findings today say aromatase inhibitors are free of tamoxifen’s more worrisome side effects, such as endometrial cancer and potentially fatal blood clots.

“Five years of treatment with tamoxifen reduces the risk of breast cancer recurrence by 47% and the risk of death by 26%,” wrote Dr. Beat Thurlimann and colleagues. “Despite these benefits, about half the women so treated relapse.”

This does not mean that Femara or other aromatase inhibitors are problem-free. The Swiss team found that women taking Femara were more likely to experience osteoporosis and higher cholesterol levels. All told, 8,010 women were analyzed in the study, which included teams in the United States and Australia.

Aromatase inhibitors are a type of antihormone therapy for post-menopausal women whose cancers are driven by estrogen. After menopause, estrogen largely comes from converted androgen hormones produced by the adrenal glands. Androgens are converted into estrogen by an aromatase enzyme. Drugs such as Femara and Arimidex, another drug in the category, blocks the conversion, much of which occurs in fat tissues.

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