FDA Approves Femara for Breast Cancer – Better than
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
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
By Dan Wilson
Best Syndication Staff Writer
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