EAST HANOVER, NJ (AFX) - Novartis AG said it has received US regulatory approval for its Femara (letrozole) drug as a treatment for use after surgery in post-menopausal women with hormone-sensitive early breast cancer.
The US approval was based on results of the Breast International Group study, which were published in the Dec 29 issue of The New England Journal of Medicine. The study compared the effectiveness and tolerability of Femara versus tamoxifen when used as initial therapy for these patients.
The study, which is ongoing, showed that Femara reduced the risk of breast cancer returning by an additional 21 pct over the reduction offered by tamoxifen. Also, patients taking Femara showed a 27 pct reduction in the risk of cancer spreading to distant parts of the body.
Femara is now the only medicine in its class approved for use as an initial treatment immediately after surgery in post-menopausal patients with hormone-sensitive early breast cancer, and following completion of five years of tamoxifen therapy, Novartis said.
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The US approval was based on results of the Breast International Group study, which were published in the Dec 29 issue of The New England Journal of Medicine. The study compared the effectiveness and tolerability of Femara versus tamoxifen when used as initial therapy for these patients.
The study, which is ongoing, showed that Femara reduced the risk of breast cancer returning by an additional 21 pct over the reduction offered by tamoxifen. Also, patients taking Femara showed a 27 pct reduction in the risk of cancer spreading to distant parts of the body.
Femara is now the only medicine in its class approved for use as an initial treatment immediately after surgery in post-menopausal patients with hormone-sensitive early breast cancer, and following completion of five years of tamoxifen therapy, Novartis said.
newsdesk@afxnews.com cmr/cmr
COPYRIGHT
Copyright AFX News Limited 2005. All rights reserved. The copying, republication or redistribution of AFX News Content,inculding by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
AFX News and AFX Financial News Logo are registered trademarks of AFX News Limited
For more information and to contact AFX: www.afxnews.com and www.afxpress.com
© 2005 AFX News
