The US FDA has granted Sanofi-aventis a six month priority review for the supplement new drug application (sNDA) for Taxotere (docetaxel) injection concentrate in combination with a current standard treatment (cisplatin and 5-fluorouracil) for advanced gastric cancer.
According to a company release, the supplement application is based on a data from a large phase III international study, TAX 325 involving 457 patients having advanced gastric cancer. Patients treated with Taxotere based chemotherapy regime (docetaxel, cisplatin and 5-fluorouracil) had a significantly improved overall survival compared to patients who received a standard treatment of cisplatin and 5-fluorouracil with a relative risk reduction in mortality of 23%. In Europe this supplement application is already under examination by EMEA on the basis of TAX 325 study.
A priority review designation is granted by the FDA to those applications that have the potential of providing a significant therapeutic advance.
“Doctors treating patients with gastric cancer urgently need and more effective therapeutic strategies and better treatment options to help patients with this devastating disease. If approved the incorporation of Taxotere into a commonly used chemotherapy regime may be the most important development in the treatment of gastric cancer in more then a decade,” said Jaffer Ajani, professor, GI Medical Oncology, The University of Texas M. D. Anderson Cancer Centre and US principal investigator of the TAX 325 study.
Taxotere is currently approved for breast cancer, lung cancer and prostrate cancer.