New indication would expand the role of Taxotere in the treatment of breast cancer

Main Category: Cancer / Oncology
Article Date: 18 May 2004 - 0:00 PDT

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Aventis Receives Priority Review Designation for the Registrational Application to Support the Use of Taxotere® in Women with Early-Stage Breast Cancer

Aventis Press Release

Strasbourg, France - Aventis announced today that the U.S. Food and Drug Administration (FDA) has granted a Priority Review designation for the registrational application to support Taxotere (docetaxel) Injection Concentrate for the treatment of women with early-stage operable breast cancer with involved axillary lymph nodes. Aventis submitted a supplemental New Drug Application (sNDA) for the additional indication on March 18, 2004. The Priority Review designation means that the FDA will target an agency action on or before September 17, 2004.

The supplemental application is based on data from a large, well-controlled phase III study that found the combination of Taxotere, doxorubicin and cyclophosphamide (TAC) to significantly improve overall survival in women with early-stage breast cancer and reduce their risk of a relapse compared with the standard regimen of 5-fluorouracil, doxorubicin and cyclophosphamide (FAC).

A Priority Review designation is assigned by the FDA for those applications that have the potential for providing a significant therapeutic advance.

"The FDA's Priority Review designation of Taxotere recognizes its potential as an important treatment option to help extend the lives of women with node positive early-stage breast cancer," said Frank Douglas, MD, PhD, Executive Vice President of Drug Innovation and Approval and a Member of the Board of Management at Aventis.

These data, from the Breast Cancer International Research Group (BCIRG) 001/ TAX 316 study, were presented at the San Antonio Breast Cancer Symposium on December 5, 2003 and demonstrated that women with node-positive, early-stage breast cancer who received a TAC after surgery experienced a 30 percent reduction in the risk of death at a 55-month follow-up and a 28 percent reduction in the chance of their cancer returning as compared to women treated with FAC. Benefit for TAC over FAC was observed regardless of nodal, hormone-receptor of HER-2/neu status.

Breast Cancer

Breast cancer is the most common cancer among women other than skin cancer. It is the second-leading cause of cancer death in women after lung cancer -- and is the leading cause of cancer death among women ages 40 to 59. More than 1,000,000 new cases of breast cancer are reported worldwide annually and more than 300,000 women die each year from the disease. The risk of a woman developing breast cancer during her lifetime is approximately 11 percent (about one in nine of all women), with about three to four percent dying of the disease.

About Taxotere

Taxotere is a key growth driver for Aventis and is the foundation of the company's oncology franchise. Taxotere is indicated for treatment of metastatic breast cancer and non-small cell lung cancer, and is being studied extensively in clinical trials for safety and efficacy in head & neck and gastric cancers. Additional Taxotere submissions to regulatory authorities for gastric cancer are planned for the second half of the year. In 2003, Taxotere generated worldwide sales of over € 1.3 billion.

About Aventis

Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of € 16.79 billion, invested € 2.86 billion in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.

Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de Référence"- on file with the "Autorité des marchés financiers" in France.

Pursuant to Article 7 of the COB Regulation no. 2002-04, this press release was transmitted to the Autorité des marchés financiers before its release.