Singapore, Nov 19, 2008: French pharma giant Sanofi-Aventis has withdrawn its application for an extension of ‘Taxotere’ and ‘Docetaxel Winthrop.’ A formal notification has been sent to The European Medicines Agency (EMEA).
The applications for the extension of indication for ‘Taxotere’ and ‘Docetaxel Winthrop’ were submitted to the EMEA in December 2007. In July 2008, the Committee for Medicinal Products for Human Use (CHMP) refused to grant extension for the medicines. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal.
Sanofi Aventis stated that the withdrawal is based on the CHMP's opinion that the study design did not adequately define the contribution of Taxotere and Docetaxel Winthrop.
Taxotere was first authorized in the European Union in 1995, while Docetaxel Winthrop was authorized in April 2007. Taxotere and Docetaxel Winthrop are currently indicated for the treatment of breast cancer, non-small cell lung cancer and prostate cancer, gastric adenocarcinoma and head and neck cancer.
Taxotere and Docetaxel Winthrop were expected to be used for the adjuvant treatment of patients with operable breast cancer whose tumors overexpress ‘Her2’ in certain combinations. The combinations include (given simultaneously) with trastuzumab following a chemotherapy regimen and in combination with trastuzumab and carboplatin.
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