Healthcare Industry News: paclitaxel
News Release - December 14, 2006
New Data On Pfizer's Aromasin and Ellence to Be Presented at San Antonio Breast Cancer SymposiumPfizer Begins a Phase III Trial to Study Sutent(R) in Patients with Advanced Breast Cancer
NEW YORK, Dec. 14 (HSMN NewsFeed) -- Results of two studies evaluating the hormonal therapy Aromasin® (exemestane tablets) and the chemotherapy Ellence® (epirubicin hydrochloride injection) will be presented at the San Antonio Breast Cancer Symposium (SABCS) December 14 - 17, 2006. In addition, Pfizer announced the initiation of a phase III clinical trial to study Sutent® (sunitinib malate) in patients with advanced (or metastatic) breast cancer -- cancer that originated in the breast and has spread to other parts of the body.
"New data are showing that Aromasin and Ellence can improve the outcomes for women with breast cancer," said Dr. Charles Baum, vice president of Pfizer Global Research and Development and oncology clinical leader. "Looking forward, we are pleased to begin studying patients with Sutent in combination with a taxane in a Phase III trial for the first-line treatment of advanced breast cancer."
* Aromasin: Efficacy in the Treatment of Early Breast Cancer Data from the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-33 study evaluates postmenopausal women with hormone receptor- positive breast cancer who, after five years of tamoxifen therapy, received either Aromasin or placebo. * Ellence: Interim Analysis of Women with High Risk Node Negative Breast Cancer A study comparing the efficacy of several common chemotherapy regimens, including Ellence, cyclophosphamide, and fluorouracil (CEF), Ellence and cyclophosphamide followed by paclitaxel (ECT) and a combination of doxorubicin and cyclophosphamide followed by paclitaxel (AC/T). * Sutent: Clinical Trials in Breast Cancer A phase III randomized open-label study of sunitinib malate in combination with paclitaxel versus bevacizumab with paclitaxel as a first-line treatment for patients with advanced breast cancer is now open and enrolling patients. The trial will enroll more than 700 patients at 20 sites across the United States. The initiation of a second phase III trial is expected in early 2007. In addition, a phase II randomized, open-label study of sunitinib malate versus standard-of- care for patients with previously treated advanced triple receptor negative (ER-, PR- and HER2-) breast cancer is currently enrolling patients at 44 international sites, including more than 25 U.S. sites. For more information about this trial, visit http://www.pfizeroncology.com/clinicaltrialpo.aspx or call 1-877-369- 9753. Key data presentations include: PRODUCT TIME ABSTRACT TITLE AROMASIN® Benefit from exemestane as extended (exemestane Dec. 15 adjuvant therapy after five years of tablets) 9:30 am tamoxifen: intent-to-treat analysis of NSABP B-33 ELLENCE® A Randomized Trial of CEF versus Dose (epirubicin Dec. 17 Dense EC followed by Paclitaxel hydrochloride 8:45 am versus AC followed by Paclitaxel in injection) women with node positive or high risk node negative breast cancer, NCIC CTG MA.21: Results of an interim analysisBackground information on studies and trials will be posted on http://www.pfizer.com after each presentations is made at SABCS.
Aromasin is indicated for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of 5 consecutive years of adjuvant hormonal therapy.
Aromasin is also indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following tamoxifen therapy.
Important Safety Information:
Aromasin should not be used in women who are premenopausal, are nursing or pregnant, have a known hypersensitivity to the drug, or are taking estrogen- containing agents.
Ellence (epirubicin hydrochloride injection) is part of a chemotherapy regimen used to treat the early stages of breast cancer when the cancer has spread to the lymph nodes. It is administered after women have undergone surgery for their cancer. This kind of chemo is called "adjuvant" therapy.
Important Safety Information:
Tissue necrosis due to extravasation could occur. Not to be given by IM or subcutaneous route; cardiotoxicity, CHF in most severe cases, may occur during or after therapy; secondary leukemia has been reported in anthracycline- treated patients. Certain factors can increase the risk for developing these conditions; dosage should be reduced in hepatically impaired patients; severe myelosuppression may occur.
DISCLOSURE NOTICE: The information contained in this release is as of December 14, 2006. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a potential additional indication for Sutent that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for this additional indication as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and in its reports on Form 10-Q and Form 8-K.
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