Sanofi gets positive European opinion on Taxotere for stomach cancer

By Elaine Rigoli

Tampa, Fla., March 24 - Sanofi-Aventis announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval in Europe of Taxotere (docetaxel) injection concentrate in combination with cisplatin and 5-fluorouracil.

The drug is intended as a treatment of patients with metastatic stomach cancer, including cancer of the gastro-esophageal junction, who have not received prior chemotherapy for their metastatic disease.

This is the first CHMP positive opinion for the treatment of advanced stomach cancer demonstrating a survival advantage in more than a decade, thereby offering physicians and their patients an important new option for treating a disease that is the second leading cause of cancer death worldwide, according to a company news release.

The Food and Drug Administration approved this supplemental indication on March 23.

The CHMP based its decision on results from the Tax 325 study, the largest international phase 3 clinical trial in previously untreated advanced stomach cancer involving 445 patients.

Patients treated with the Taxotere-based chemotherapy regimen experienced a significant 23% reduction in the risk of death compared to patients who received a current standard treatment of cisplatin and 5-fluorouracil, the release said.

The median overall survival was significantly longer with the Taxotre-containing regimen with a hazard ratio of 1:29.

Sanofi-Aventis is a Paris-based international pharmaceutical company.

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