TAXOTERE GETS FDA APPROVAL FOR USE IN ADVANCED STOMACH CANCER

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Sanofi-aventis announced today that following a priority review of the supplemental new drug application (sNDA), the FDA has approved Taxotere (docetaxel) injection Concentrate in combination with cisplatin and 5- fluorouracil for the treatment of patients with advanced stomach (gastric) cancer, including cancer of the gastro esophageal junction, who have not received prior chemotherapy for advanced disease.

This is the first FDA approval of an advanced stomach cancer treatment demonstrating a survival advantage in more than a decade, thereby offering physicians and their patients an important new option for treating this devastating disease. The additional new application is also currently under review by the Committee for Medicinal Products for Human Use of the European Agency for the Evaluation of Medicinal Products.