FDA Approves New Use for Breast Cancer Drug
Aromasin May Now Treat Early Breast Cancer in Postmenopausal Women
Oct. 6, 2005 -- The FDA has approved a new use of the breast cancer drug
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
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.
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
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
Those who were switched to Aromasin had 32% more protection from cancer's
"[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.
Aromasin is part of a newer family of breast cancer drugs called aromatase
inhibitors. Those drugs also include