Sanofi-Aventis’ Taxotere gets two new European approvals

The first approval granted Taxotere (docetaxel), 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 Roche and Genentech’s Herceptin (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 a pivotal Breast Cancer International Research Group (BCIRG) trial demonstrated a better efficacy of Taxotere-based regimen over the standard FAC (5-fluoro-uracil, doxorubicin and cyclophosphamide) with a significant 28% reduction in risk of relapse and a 30% reduction in risk of death after 55 months of follow-up.

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

For the treatment of metastatic breast cancer that over-expresses Her2 (more aggressive tumors), an international randomized clinical trial 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 Michel Marty of the Institut Gustave Roussy, France and principal investigator of the trial. “These patients concerned by a more aggressive tumor should benefit from this innovative regimen today.”