Women's Health Weekly
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Breast Cancer Therapy
Femara granted FDA priority review for new indication: early breast cancer
September 29th, 2005
Novartis announced that the U.S. Food & Drug Administration (FDA) has granted priority review to Femara (letrozole tablets) in the adjuvant (postsurgery) treatment of postmenopausal women with hormone receptor-positive early breast cancer. The FDA grants priority review to products that could potentially offer a significant improvement compared to marketed products in the treatment, diagnosis, or prevention of a disease. Novartis asked for consideration for priority review based on enhanced efficacy in high-risk subgroups for which existing therapies have not demonstrated benefit. Specifically, Femara showed significantly improved efficacy compared...
Source: Women's Health Weekly (2005-09-29)
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