Sanofi-aventis gets FDA priority review for Taxotere gastric cancer drug

By Ted A. Knutson

Washington, Dec. 2 - Sanofi-Aventis announced Friday the Food and Drug Administration has granted a six-month priority review for the supplemental New Drug Application for Taxotere (docetaxel) Injection Concentrate, in combination with a current standard treatment (cisplatin and 5-fluorouracil) for advanced gastric cancer.

The supplemental application is based on data from a large phase 3 international study, TAX 325, involving 457 patients with advanced gastric cancer.

Patients treated with a Taxotere-based chemotherapy regimen (docetaxel, cisplatin and 5-fluorouracil) had a significantly improved overall survival compared to patients who received a standard treatment of cisplatin and 5-fluorouracil (9.2 months vs. 8.6 months median survival) with a relative risk reduction in mortality of 23% and a two-year survival of 18% versus 9% in favor of the Taxotere arm.

In Europe this supplemental application is already under examination by the EMEA on the basis of the TAX 325 study results.

"Doctors treating patients with gastric cancer urgently need new and more effective therapeutic strategies and better treatment options to help patients with this devastating disease," said Jaffer A. Ajani, professor, GI Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, the U.S. principal investigator of the TAX 325 study. "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."

Sanofi-Aventis is a Paris-based biotechnology company.

The announcement was made in a 6-K filing with the Securities and Exchange Commission.

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