Updated adjuvant data presented at SABCS show 30 percent reduction in ...( San Antonio December 8 Pfizer announc...),Health

San Antonio, December 8 Pfizer announced today that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for AROMASIN (exemestane tablets) in the adjuvant treatment of postmenopausal women with estrogen receptor positive or receptor unknown early-stage breast cancer.

AROMASIN is a hormonal therapy that belongs to a class of drugs called aromatase inhibitors which work by blocking the production of estrogen, which is known to play a key role in the development and growth of breast cancer. For many years, treatment with tamoxifen has been the standard hormonal therapy for postmenopausal women with breast cancer that is dependent upon estrogen for growth. Results from the pivotal Intergroup Exemestane Study (IES), published in the New England Journal of Medicine, demonstrated that postmenopausal breast cancer patients who had been treated with 2-3 years of tamoxifen for early breast cancer (adjuvant treatment with tamoxifen) and were switched to AROMASIN significantly reduced their risk of recurrence and increased disease-free survival compared to patients who remained on tamoxifen for the entire five years.

"The adjuvant approval of AROMASIN would provide oncologists with a treatment regimen that significantly reduces the recurrence of breast cancer," said Dr. Stephen Jones, medical director at U.S. Oncology Research. "This filing is an important step toward providing postmenopausal women with a critical treatment option that can significantly improve survival of early breast cancer when compared to tamoxifen."

Pfizer's announcement closely follows newly released American Society of Clinical Oncology (ASCO) recommendations on the use of aromatase inhibitors as adjuvant therapy for postmenopausal women with hormone-receptor-positive breast cancer and coincides with the presentation of an update on the study trial being used to support the filing. The ASCO recommendations,
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Contact: Steven Cooper
steven.cooper@edelman.com
917-301-7566
Edelman Public Relations
8-Dec-2004

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