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FDA okays new breast cancer drug

Associated Press
Published December 29, 2005


Women now have another drug they can take to prevent breast cancer from returning after surgery to remove the tumor.

The Food and Drug Administration on Wednesday approved a new use for Femara, a medication already licensed for treating advanced breast cancer. It now can be given as initial therapy to women past menopause who have early breast cancer, the agency said.

In today's New England Journal of Medicine, a study reports that Femara was more effective at preventing recurrences than the current gold standard, tamoxifen.

Femara and Arimidex, a similar drug already licensed, are aromatase inhibitors, which block production of estrogen, a hormone that fuels the growth of most tumors that develop after menopause. Tamoxifen works differently, by blunting the ability of estrogen to enter cells.

The study estimated 84 percent of women given Femara versus 81 percent of those on tamoxifen would have no signs of cancer five years after starting treatment.

The estimates were based on two years of information on relapses among the 8,000 women in the study.