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European Approval Conveyed on Exemestane Tablets as Adjuvant Treatment of Invasive Early Breast Cancer

NEW YORK, Sept. 13 /PRNewswire-FirstCall/ -- Pfizer Inc said today that it has received European Mutual Recognition Procedure (MRP) approval to market Aromasin(R) (exemestane tablets) for a new indication, adjuvant treatment of estrogen receptor positive invasive early breast cancer following two-to-three years of initial adjuvant tamoxifen therapy in postmenopausal women.

Aromasin is a hormonal therapy, used to treat women with breast cancers that depend on a hormone, specifically estrogen, for growth and survival. An estimated two-thirds of breast cancer cases are estrogen-dependent.

The approval was based on the Intergroup Exemestane Study (IES) that showed patients who switched to Aromasin after two to three years of tamoxifen had a 31 percent better probability of disease-free survival than those who remained on tamoxifen.

"All patients deserve to have the greatest possibility of living disease free. For too long, patients with breast cancer have simply been given tamoxifen for five years hoping that it works. Patients now have an extra option -- at no increased risk in terms of side effects," said Prof. R. Charles Coombes, Imperial College, Hammersmith Hospital, London and lead investigator of the IES study. "They can simply switch after two-to-three years of taking tamoxifen to exemestane."

Data from the IES study supporting the new indication for Aromasin was published in the New England Journal of Medicine in March 2004. The trial involved over 4,700 postmenopausal women with estrogen-receptor positive breast cancer who were followed for an average of 35 months. Patients receiving Aromasin experienced a significant reduction in the risk for recurrence of the disease, as compared to those continuing on tamoxifen. This reduction includes fewer local and distant tumors as well as new cancer in the other breast.

In the IES study, treatment with Aromasin was associated with fewer of the potentially serious side effects commonly associated with tamoxifen, including a significant reduction in thromboembolic events. Additionally, Aromasin had no significant impact on bone fracture rate.

Aromasin is well tolerated and the side effects associated with the treatment are generally mild to moderate. Aromasin should not be administered to pre-menopausal women and women who are pregnant. Dose modifications should be considered for patients taking concomitant potent CYP3A4 inducers. In patients with early breast cancer the most commonly reported adverse reactions were hot flushes (22%), arthralgia (17%) and fatigue (17%). In patients with advanced breast cancer the most commonly reported adverse reactions were hot flushes (14%) and nausea (12%).

Breast cancer is the most common cancer occurring in women (excluding cancers of the skin) and the second leading cause of death from cancer in women, after lung cancer. Each year, an estimated 200,000 women in the European Union are diagnosed with breast cancer and approximately 80,000 women die of the disease. Adjuvant therapy is treatment given following surgical removal of a primary tumour (the first tumour that occurs before it spreads to other parts of the body).

The UK acted as the Reference Member State for the European Mutual Recognition Variation Procedure, which covers 15 other countries. Subsequently, the UK national approval was granted, and similar national approvals in the rest of the MRP countries of the new early breast cancer indication are expected in the near future. Aromasin has also been newly approved for use in early breast cancer in Switzerland and New Zealand.

In 1999, Aromasin was approved in Europe through Mutual Recognition Procedure for treatment of advanced breast cancer after prior anti-estrogen therapy. The U.S. Food and Drug Administration approved Aromasin for advanced breast cancer in post menopausal women whose disease has progressed following tamoxifen therapy in late 1999. Currently, Aromasin is available in more than 50 countries around the globe.

Source: Pfizer Inc

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