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Novartis Femara

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approves letrozole Jan. 10 for first-line treatment of hormone receptor-positive or hormone receptor-unknown advanced metastatic breast cancer in postmenopausal women. Femara was shown to be superior to tamoxifen in median time to tumor progression and rate of objective tumor response in a Phase III trial, labeling states. The sNDA for the new indication, submitted July 2000, was given priority review status. Femara has been approved for second-line treatment of advanced breast cancer in postmenopausal women since 199

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