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FDA Approves Femara for Breast Cancer – Better than Tamoxifen

December 29th 2005

FDA Approves Femara for Breast Cancer – Better than Tamoxifen


Femara is now approved for treating early stage breast cancer in women past menopause.  Yesterday the FDA (Food and Drug Administration) granted Novartis, the manufacturer of Femara, this approval.  The drug has already been used to treat late stage breast cancer. 

Femara belongs to the class of drugs called aromatase inhibitors. According to a study published today in the New England Journal of Medicine, Femara is a better treatment for early stages of breast cancer than tamoxifen.  Femara does not have the side affects associated with Tamoxifen either.  These side effects have included endometrial cancer, and potentially fatal blood clots.


"Five years of treatment with tamoxifen reduces the risk of breast cancer recurrence by 47 percent and the risk of death by 26 percent," according to Dr. Beat Thurlimann and colleagues. "Despite these benefits, about half the women so treated relapse.” Women past menopause now have a better option to treat early-stage breast cancer, with the approval of a Femara, a drug aimed at staving off recurrences.

The study published today found some problems with Femara.  The Swiss researchers with teams in the United States and Australia found that women taking Femara were more likely to experience osteoporosis, higher levels of cholesterol and possible heart problems.  The team studied 8,010 women.

The FDA decision will allow Novartis to market the drug to post –menopausal women with early hormone-positive breast cancer, or to patients whose cancer depends on estrogen to grow.  The treatment begins right after surgery.  This is known as early adjuvant setting therapy and is a systemic approach to fighting microscopic metastatic disease after surgical resection of the primary tumor.


This is likely to benefit women in the highest risk group where cancer has spread to the lymph nodes.  In fact, when the cancer has spread the drug cut the risk of recurrence of disease by 29% compared to tamoxifen.   According to the BBC “Among all women taking Femara there was a 27% reduction in the risk of cancer spreading to other parts of the body compared to those taking tamoxifen, and a 19% drop in the risk of breast cancer returning. A global study found Femara (letrozole) was of most benefit to women at highest risk of the cancer returning, the New England Journal of Medicine reported.”

The BBC also reported that Nigel Bundred, a professor in surgical oncology at Wythenshawe Hospital, Manchester, said: "These results are fantastic news and give hope to women with breast cancer - especially those at high risk of their cancer recurring.

"They show that Femara is more effective than tamoxifen when given to women after surgery and offers even greater advantages to these particularly vulnerable women."
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By Dan Wilson
Best Syndication Staff Writer

Diet Books

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Copyright 2005 Best Syndication                                            Last Updated Saturday, July 10, 2010 09:41 PM