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Letrozole Gains FDA Approval as Post-Tamoxifen Treatment for Early Breast Cancer

EAST HANOVER, N.J., Oct. 29 /PRNewswire/ -- 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 (e.g., post-surgery) tamoxifen therapy for five years, Novartis announced today.

"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, M.D., 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 term extended adjuvant describes the period following adjuvant treatment with tamoxifen. Even years after breast cancer diagnosis and primary treatment, the ongoing risk of breast cancer recurrence remains significant for all patients. Approximately one-third of women with estrogen receptor-positive early breast cancer experience a recurrence and over half of those recurrences occur more than five years after surgery. While tamoxifen is beneficial for five years post surgery, if used beyond that, the risks associated with it outweigh the benefits. Extended adjuvant treatment with Femara is the first therapy to effectively reduce 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, which included more than 5,100 postmenopausal women and was coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University in Kingston, Ontario, and supported by Novartis. Initial results were published in the New England Journal of Medicine in October 2003.

The study showed that Femara reduced the risk of cancer coming back, or disease-free survival, by 38% and significantly increased a woman's chance of staying cancer-free. This is particularly important because when breast cancer recurs, it very often has spread beyond the breast (metastatic disease), which can have serious consequences. Femara also greatly reduced the chance of breast cancer returning to another part of the body, or distant metastases, by 39%.


Femara, a leading, once-a-day oral aromatase inhibitor, is also indicated for first-line treatment of postmenopausal women with hormone receptor- positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Novartis has filed in the European Union for the indication of extended adjuvant treatment of early breast cancer in postmenopausal women who have completed standard adjuvant (post-surgery) tamoxifen therapy. In addition to the U.S., this indication is now approved in the United Kingdom, Switzerland, Mexico, Korea and other countries around the world. Femara is currently available in more than 80 countries worldwide. Not all indications are available in every country.

Femara Contraindications and Adverse Events

Side effects commonly reported with Femara are generally mild to moderate. In the extended adjuvant setting, those seen more often with Femara than with placebo are hot flashes (50% to 43%) arthralgia/arthritis (29% vs. 23%) and myalgia (7% vs. 5%). In a clinical trial, osteoporosis was reported more frequently with Femara than with placebo (7% vs. 6%). During treatment, both arms of the trial showed expected modest decreases in bone mineral density in the hip and spine.

Femara may cause fetal harm when administered to pregnant women. You should not take Femara if you are allergic to Femara or any of its ingredients.

Source: Novartis

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