Breast Cancer

U.S. FDA approves Aromasin for adjuvant treatment of early breast cancer in postmenopausal women

Published in Medical Letter on the CDC and FDA, November 6th, 2005

Pfizer, Inc., has received approval from the U.S. Food & Drug Administration (FDA) to market Aromasin (exemestane tablets) for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer following 2-3 years of tamoxifen for a completion of 5 consecutive years of adjuvant hormonal therapy.

The approval was based on the Intergroup Exemestane Study (IES) which showed that patients who switched to Aromasin after 2-3 years of tamoxifen, for a combined total of 5 years of therapy, had 31% more protection from cancer recurrence than those who remained on 5 years of tamoxifen therapy.

This landmark study, published in the...

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Source: Medical Letter on the CDC and FDA (2005-11-06)

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