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.
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 cancer.
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.