Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health) | Oncology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved January 1996
Treatment Area: post menopausal breast cancer
Arimidex has been approved as a treatment for advanced breast
cancer in postmenopausal women whose disease has progressed
following therapy with tamoxifen.
The FDA made its decision after evaluating results of clinical
studies involving more than 750 subjects. Results from the two
studies showed that Arimidex is effective in the treatment of
advanced breast cancer.
Most commonly reported side effects, regardless of causality,
included fatigue, nausea, headache, hot flashes, pain and back
pain. Arimidex is not associated with significant weight gain
reported with progestins.
Mechanism of Action
Results from studies suggest that growth of some breast cancer
tumors is stimulated by the female hormone estrogen. Arimidex, a
nonsteroidal compound, is the first entry in a new class of
third-generation selective oral aromatase inhibitors. Inhibition of
aromatase reduces the production of estrogen. Thus, Arimidex
reduces serum concentration of estrogen, an effect that has been
shown to be of benefit in postmenopausal women with breast
Approximately one woman in eight will develop breast cancer in
her lifetime. According to the American Cancer Society, an
estimated 184,300 women will be diagnosed with breast cancer in
1996. It is estimated that about 6% of patients with breast cancer
in the United States. have advanced breast cancer.