Sanofi withdraws new Taxotere use MAA

French drug major Sanofi-Aventis has withdrawn two European Marketing Authorization Applications to extend the indications of docetaxel products.

The European Medicines Agency (EMEA) says that Sanofi withdrew its applications for Taxotere (docetaxel) and Docetaxel Winthrop to be approved for the adjuvant treatment of operable breast cancer patients whose tumors over-express the HER2 receptor.

Both applications were submitted at the end of last year and the EMEA's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion in July, 2008, stating that the design of the studies featured in the application did not adequately define the contribution of the drugs to treatment of the disease. Sanofi had requested a re-examination of the application, which the Agency says was underway when it was notified of the withdrawal.