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FDA Approves Afinitor for Advanced Breast Cancer

The FDA announced on July 20 that Afinitor (everolimus) has been approved for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The drug combination is intended for use in women with recurrent or progressive cancer after treatment with Femara (letrozole) or Arimidex (anastrozole). Breast cancer is the second leading cause of cancer-related death among women. This year, an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will die from the disease. The FDA’s decision marks the first approval from the class of drugs known as mammalian target of rapamycin (mTOR) inhibitors for the treatment of postmenopausal women with advanced hormone receptor-positive breast cancer. The safety and effectiveness of Afinitor were evaluated in a clinical study of 724 patients with advanced breast cancer. All of the patients had experienced menopause; had metastatic, estrogen receptor-positive, HER2-negative breast cancer; and had previously received treatment with Femara or Arimidex. Patients were randomly assigned to treatment with either Afinitor in combination with Aromasin or Aromasin with placebo. Patients received treatment until their cancers progressed or side effects became unacceptable. Patients who received Afinitor plus Aromasin showed a 4.6-month improvement in the median time to disease progression or death compared with patients receiving Aromasin plus placebo. The FDA previously approved Afinitor for the treatment of patients with advanced renal cell carcinoma that has progressed after treatment with other cancer therapies in adult patients with progressive advanced neuroendocrine tumors of pancreatic origin; for patients with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery; and for adults and children with subependymal giant-cell astrocytoma associated with TSC who require treatment but are not candidates for curative surgery. Afinitor is marketed by Novartis. Visit the FDA's Web site for more information.
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