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Docetaxel Receives Two New European Approvals for Treatment of Breast Cancer

PARIS, Jan. 11 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the European Commission has approved 2 new indications for Taxotere(R) (docetaxel) Injection Concentrate for treatment of breast cancer.

The first granted TAXOTERE(R), in combination with doxorubicin and cyclophosphamide, for the adjuvant treatment of patients with operable node- positive breast cancer.

A second granted TAXOTERE(R), in combination with Herceptin(R) (trastuzumab), for the treatment of patients with metastatic breast cancer whose tumors over-express the Her2 gene.

The Commission approval is based on the results of two separate large randomized international trials.

* In adjuvant setting, second interim analysis from the pivotal Breast Cancer International Research Group (BCIRG) 001/TAX 316(1) trial demonstrated a better efficacy of TAXOTERE(R) based regimen over the standard FAC (5-fluoro-uracil, doxorubicin and cyclophosphamide) with a significant 28 percent reduction in risk of relapse and a 30 percent reduction in risk of death after 55 months of follow-up.

TAXOTERE(R) is the only drug from its class to demonstrate such survival benefit regardless of woman's hormone receptor status.

"These results bring new hope for all the women with operable node- positive breast cancer. With Taxotere, about 9 women on 10 are alive at 5 years, that is 30 % of additional reduction of the risk of mortality" said Dr Jean-Paul Guastalla (Leon Berard center, Lyon- France) and investigator of the trial.

"The addition of Taxotere to this standard therapeutic strategy would save 18 000 additional lives at 5 years in the world" commented Dr Miguel Martin (Hospital Clinico San Carlos, Madrid- Spain), President of the GEICAM (Grupo Espanol de Investigacion en Cancer de Mama) and member of the BCIRG steering committee.

* For the treatment of metastatic breast cancer that over-expresses Her2 (more aggressive tumors), international randomized clinical trial M77001(2) demonstrated a better efficacy of TAXOTERE(R)-trastuzumab combination with significant improvement of overall survival as well as significant improvement of other efficacy endpoints (objective response rate, time to progression, median survival).

"It is a true advance for all these patients with a breast cancer that can increase and spread very quickly," said Pr Michel Marty (Institut Gustave Roussy, France), principal investigator of the trial. "These patients concerned by a more aggressive tumor should benefit from this innovative regimen today," he concluded.

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 400,000 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 worldwide). In the European Union, 191,000 new cases will be diagnosed, and more than 60,000 European women will die of the disease. In the United States, more than 215,000 American women will be diagnosed with breast cancer this year, and 40,000 will die of the disease.

Her2 is a protein present in some breast cancers. When there are high levels of Her2 the breast cancer is known as over-expressing Her2 or Her2- positive. This affects around one in five women and the cancer can increase and spread very quickly because it encourages the cancer cells to divide and grow.

Earlier diagnosis of breast cancer results in earlier treatment and may offer better chance for cure.

About Taxotere(R)
Docetaxel (TAXOTERE(R)), a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Docetaxel promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in death in some cancer cells.

TAXOTERE(R) is indicated for treatment of metastatic breast cancer, non- small cell lung cancer, and androgen-independent (hormone-refractory) metastatic prostate cancer. TAXOTERE(R) is being studied extensively in clinical trials for safety and efficacy in early-stage breast, Head and Neck and gastric cancers.

Important safety information
WARNING: Taxotere(R) treatment can cause serious, physically limiting, and potentially life-threatening side effects, such as infection, low blood-cell counts, allergic reaction, and retention of excess fluid (edema).

Taxotere(R) should not be given to patients with low white-blood-cell counts, abnormal liver function, or a history of allergic reactions to Taxotere(R) or any of the ingredients in Taxotere(R).

Taxotere(R) should be administered only under the supervision of a qualified physician experienced in the use of anticancer treatments. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Treatment-related acute myeloid leukemia (AML) has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere(R) in adjuvant therapy for breast cancer.

Because of the potential risk of fetal harm, pregnant women should not receive Taxotere(R). Women of childbearing potential should avoid becoming pregnant during treatment with Taxotere(R).

For more information about Taxotere(R), visit http://products.sanofi.us/taxotere/taxotere.html or see full prescribing information including boxed WARNING. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit http://www.aventisoncology.com/.

Source: Sanofi-aventis

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