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Results In 'The New England Journal Of Medicine' Confirm Novartis Drug Femara(R) Is Superior To Tamoxifen After Breast Cancer Surgery
Date:8/19/2009

With the long-term follow-up in the analysis conducted more than 10 years after the start of the study, adverse events for Femara and tamoxifen were found to be consistent with the known safety profiles of both drugs. Patients will be monitored for the rest of their lives to track disease status, safety and overall survival. The long-term BIG 1-98 findings add to the large body of clinical evidence regarding the established safety profile of Femara.

About Femara

Femara((R)) (letrozole tablets) is approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone receptor-positive early stage breast cancer. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, safety and efficacy.

Femara is also approved for the extended adjuvant treatment of early stage breast cancer in postmenopausal women who are within three months of completion of five years of tamoxifen therapy. The benefits of Femara in clinical trial are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, including side effects.

In addition, Femara is approved for the treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown breast cancer that has spread to another part of the body (metastatic cancer).

Important Safety Information

You should not take Femara if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. Femara is only indicated in postmenopausal women. Talk to your doctor if you're allergic to Femara or any of its ingredients. You should not take Femara if you are pregnant as it may cause fetal harm. Some women reporte
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SOURCE Novartis Pharmaceuticals Corporation
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