Aventis announced 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 per cent reduction in the risk of death at a 55-month follow-up and a 28 per cent 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 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 per cent (about one in nine of all women), with about three to four percent dying of the disease.

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.