Sanofi-aventis announced that the European Commission has approved 2 new indications for Taxotere (docetaxel) Injection Concentrate for treatment of breast cancer.

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

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

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

Taxotere is the only drug from its class to demonstrate such survival benefit regardless of woman's hormone receptor status, the company says.

"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 per cent of additional reduction of the risk of mortality," said Dr Jean-Paul Guastalla, investigator of the trial.

For the treatment of metastatic breast cancer that over-expresses Her2 (more aggressive tumours), international randomized clinical trial M77001 (2) demonstrated a better efficacy of Taxotere-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 Professor Michel Marty, principal investigator of the trial. "These patients concerned by a more aggressive tumour should benefit from this innovative regimen today" he concluded.

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

In 2003, Taxotere generated worldwide sales of over € 1.3 billion.