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Femara gains U.S. FDA approval as only post-tamoxifen treatment for early breast cancer.

New treatment option -- the first to help postmenopausal women with early breast cancer remain cancer-free following post-surgery tamoxifen therapy.

Femara (letrozole) is the first therapy approved by the U.S. Food and Drug Administration (FDA) for the extended post-surgery treatment of postmenopausal women with early breast cancer who have received post-surgery tamoxifen therapy for five years, Novartis recently 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, M.D., vice president and global head of Clinical Development at Novartis Oncology. “This priority review approval marks the first time that nearly 100,000 women who complete tamoxifen therapy each year will have a medical option to reduce their ongoing risk of breast cancer recurrence.”

The term extended post-surgery describes the period following post-surgery treatment with tamoxifen. Even years after breast cancer diagnosis and primary treatment, the ongoing risk of breast cancer recurrence remains significant for all patients. Globally, 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 period, the risks associated with it outweigh the benefits. Extended post-surgery treatment with Femara is the first therapy to effectively reduce ongoing risk of breast cancer recurrence.

The approval for the extended post-surgery 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, Canada, 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 has very often 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%.

About Femara
Femara is a leading once-a-day aromatase inhibitor that is also indicated for first-time 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 and as pre-operative 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.

Femara contraindications and adverse events
The next most common adverse events experienced with Femara are hot flashes, arthralgia/arthritis and myalgia. Other commonly reported adverse reactions are nausea, fatigue, anorexia, appetite increase, peripheral oedema, headaches, dizziness, vomiting, dyspepsia, constipation, diarrhea, alopecia, increased sweating, rash, myalgia, bone pain, arthritis/arthralgia, and weight increase.

Femara is contraindicated in women who are pregnant or breast-feeding as well as in women with premenopausal endocrine hormone receptor status. Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients.

Additional information regarding Femara or Novartis Oncology can be fond on the websites www.femara.com or www.novartisoncology.com.