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Femara early adjuvant approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis' aromatase inhibitor Femara (letrozole) clears FDA Dec. 28 for adjuvant treatment of postmenopausal women with hormone-sensitive early breast cancer. Femara is the only medicine in its class approved for use in that setting as well as in the extended adjuvant setting following tamoxifen, Novartis says. Approval is based on the 8,000-patient Breast International Group (BIG 1-98) study showing an additional 21% reduction in risk of recurrence over tamoxifen (1Pharmaceutical Approvals Monthly August 2005, p. 13). Novartis' promotion of the new indication will be boosted by publication of the pivotal data supporting the sNDA in the Dec. 29 issue of The New England Journal of Medicine...

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