AROMASIN (exemestane) is indicated for the sequential adjuvant treatment of postmenopausal women with estrogen receptor-positive early breast cancer who have received 2-3 years of initial adjuvant tamoxifen therapy.
Approval is based on improved disease-free survival for sequential AROMASIN in comparison to continuous tamoxifen. However, overall survival was not significantly different between the two treatments (see PART II, CLINICAL TRIALS).
AROMASIN (exemestane) is also indicated for hormonal treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status whose disease has progressed following antiestrogen therapy.