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Femara gets U.S. FDA nod as post-tamoxifen treatment for early breast cancer.

Women's Health Weekly

| December 02, 2004 | COPYRIGHT 2004 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2004 DEC 2 - (NewsRx.com & NewsRx.net) -- Femara (letrozole tablets) is the first therapy approved by the U.S. Food and Drug Administration for the extended adjuvant treatment of postmenopausal women with early breast cancer who have received adjuvant (postsurgery) tamoxifen therapy for 5 years, Novartis announced.

"Femara truly provides hope to women who have survived early breast cancer by offering them an improved chance of remaining cancer-free," said Diane Young, MD, vice president, global head, clinical development, Novartis oncology. "This priority review approval marks the first time that the nearly 100,000 women in the United States who complete tamoxifen therapy each year will have a medical option to reduce their ongoing risk of breast cancer recurrence."

The approval for the extended adjuvant indication was based on results from the landmark, international, independent MA-17 study, ...

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