FDA prioritizes Sanofi-Aventis drug for gastric cancer

A priority review designation is assigned by the FDA for those applications that have the potential for providing a significant therapeutic advance.

“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 Dr Jaffer Ajani from The University of Texas MD Anderson Cancer Center, and principal investigator of the 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.”

The supplemental application is based on data from a phase III international study involving 457 patients with advanced gastric cancer. In the trial patients treated with a Taxotere-based chemotherapy regimen (Taxotere, 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).

The drug also produced a relative risk reduction in mortality of 23%, and a 2-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 study results.

Taxotere is already approved in the US for various indications within breast cancer, non small cell lung cancer, and prostate cancer.