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FDA Approves New Use for Breast Cancer Drug

Aromasin May Now Treat Early Breast Cancer in Postmenopausal Women
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WebMD Health News

Oct. 6, 2005 -- The FDA has approved a new use of the breast cancer drug Aromasin.

Aromasin, an aromatase inhibitor, may now be used to treat early breast cancer in postmenopausal women with estrogen-sensitive breast cancer who have already taken another breast cancer drug, tamoxifen, for two to three years.

That would give those women a total of five consecutive years of hormone therapy treatment after breast cancer treatment (starting with tamoxifen and ending with Aromasin).

Breast cancer is women's most common cancer, except for nonmelanoma skin cancers. More women are surviving breast cancer. Of course, it's still a must to see a doctor for any breast concerns and to get recommended breast cancer screening, even if you feel fine.

According to the American Cancer Society, there are more than 2 million breast cancer survivors in the U.S. (some of them are men). Lung cancer is women's No. 1 cause of cancer deaths.

New Use for Aromasin

Aromasin is not a brand-new drug. It was approved in the U.S. in 1999 to treat advanced breast cancer in postmenopausal women whose tumors have stopped responding to tamoxifen.

Other medications like Aromasin include the aromatase inhibitors Arimidex, and Femara. They are used in postmenopausal women with estrogen-sensitive breast cancer and lower the amount of estrogen that is in the body, which can make these breast cancers grow.

Femara is made by Novartis. Arimidex is made by AstraZeneca. Both companies are WebMD sponsors.

The original approval of Aromasin remains in place. The FDA's latest decision just extends Aromasin's approval to postmenopausal women with early breast cancer following two to three years of tamoxifen.

Aromasin should not be taken by premenopausal women and women who are pregnant, states Pfizer, the maker of Aromasin. Pfizer is a WebMD sponsor.

FDA's Decision

According to a Pfizer news release, the FDA approved Aromasin's new use based on a study of more than 4,700 postmenopausal women with estrogen receptor-positive breast cancer.

That study was published in The New England Journal of Medicine in March 2004.

All of the women had taken tamoxifen for two to three years. About half were then switched to Aromasin; others kept taking tamoxifen. Each woman got a combined total of five years of drug therapy. They didn't know which drug they were taking.

Those who were switched to Aromasin had 32% more protection from cancer's return.

"[Aromasin] therapy after two to three years of tamoxifen therapy significantly improved disease-free survival as compared with the standard five years of tamoxifen treatment," the researchers wrote.

Severe side effects were rare in their study.

Aromatase Inhibitors

Aromasin is part of a newer family of breast cancer drugs called aromatase inhibitors. Those drugs also include Femara and Arimidex.

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