Sanofi-Aventis's Taxotere gets FDA OK for treatment of stomach cancer

By Angela McDaniels

Seattle, March 23 - Sanofi-Aventis said the Food and Drug Administration has approved Taxotere (docetaxel) Injection Concentrate in combination with cisplatin and 5-fluorouracil for the treatment of patients with advanced stomach cancer, including cancer of the gastro-esophageal junction, who have not received prior chemotherapy for advanced disease.

This is the first FDA approval of an advanced stomach cancer treatment demonstrating a survival advantage in more than a decade, according to a company news release.

The new application is also under review by the European Agency for the Evaluation of Medicinal Products.

The supplemental New Drug Application for Taxotere included results from the TAX 325 study, an international phase 3 clinical trial in 445 patients with previously untreated advanced stomach cancer.

Sanofi-Aventis said that patients treated with the Taxotere-based chemotherapy regimen - Taxotere plus cisplatin and 5-fluorouracil - experienced a statistically significant 23% reduction in the risk of death compared to patients who received a current standard treatment of cisplatin and 5-fluorouracil. The median follow up time was 23 months.

The median overall survival was significantly longer with the Taxotere-containing regimen: 9.2 months versus 8.6 months for the standard treatment, the company said. Time to disease progression was nearly two months longer in the Taxotere-containing arm: 5.6 months versus 3.7 months for the standard treatment.

With this new indication, Taxotere is now approved for six indications in the United States in four different tumor types, including breast cancer, non-small cell lung cancer, prostate cancer and stomach cancer.

Stomach cancer is the fourth most common type of cancer worldwide with more than 934,000 new patients every year, according to the release. It is also the second most common cause of cancer death worldwide with more than 700,000 deaths annually. At diagnosis, most patients have advanced disease and an expected two-year survival of only 11.5%.

Sanofi-Aventis is a pharmaceutical company based in Paris.

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