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Approval In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer's Aromasin for early breast cancer: Pfizer's oncologic Aromasin (exemestane) clears FDA Oct. 5 for adjuvant treatment of early breast cancer in patients crossing over from tamoxifen therapy. Aromasin's additional indication is for "adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer following two to three years of tamoxifen for a completion of five consecutive years of adjuvant hormonal therapy," Pfizer says. The firm's Intergroup Exemestane Study found a 31% reduced risk of recurrence in patients switching to Aromasin versus those remaining on tamoxifen. Aromasin previously was approved for advanced breast cancer in patients whose disease progressed following tamoxifen therapy...
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