The FDA approved the use of anastrozole (Arimidex) for the adjuvant treatment of hormone-receptor positive early breast cancer in postmenopausal women.
In September 2002, the FDA approved a supplemental new drug application (sNDA) for Arimidex under the provisions for accelerated approval, with further follow-up required for full approval. The supplemental approval was based on recurrence-free survival data from the Arimidex Tamoxifen Alone or in Combination (ATAC) trial with a median duration treatment of 31 months.
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ARIMIDEX is an aromatase inhibitor indicated for:
• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
• Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX