Sanofi-Aventis’ big-selling cancer drug Taxotere (docetaxel) has been granted a six-month priority review by the US Food and Drug Administration for a new use, the treatment of advanced gastric cancer.
Taxotere is already approved for treating breast, lung and prostate cancers, and clinical studies have shown that it s also effective for stomach cancer when used in conjunction with the current standard treatment based on cisplatin and 5-fluorouracil.
Sanofi-Aventis said the FDA priority review was granted on the basis of the TAX 325 Phase III study, which found that adding Taxotere to standard treatment raised two-year survival among advanced gastric cancer patients to 18% from 9% for cisplatin/5-FU alone.
"If approved, the incorporation of Taxotere into a commonly used chemotherapy regimen may be the most important development in the treatment of advanced gastric cancer in more than a decade," said Jaffer Ajani, one of the directors of the TAX 325 study.
Sanofi-Aventis has also filed for approval of the gastric cancer indication in Europe. Taxotere is currently the firm’s second-biggest selling product, bringing in revenues of 420 million euros in the third quarter of this year.