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Taxotere OK'D for Advanced Stomach Cancer

Posted on: Thursday, 23 March 2006, 18:00 CST

Sanofi-aventis said Thursday it has been cleared for U.S. marketing of Taxotere for advanced stomach cancer.

The drug maker said the Food and Drug Administration OK'd Taxotere (docetaxel) Injection Concentrate for use in combination with cisplatin and 5-fluorouracil for the treatment of patients with advanced stomach cancer and gastro esophageal cancer who have not received prior chemotherapy.

Sanofi said the FDA clearance marks the first in more than 10 years of an advanced stomach-cancer therapy that has been shown to improve survival.

The company added that European approval of Taxotere for the same indication is still pending.

In a study involving 445 patients, those getting a Taxotere-based chemotherapy regimen -- Sanofi's drug combined with 5-fluorouracil -- showed a 23-percent reduction in the risk of death, compared to patients who received the standard treatment duo of cisplatin and 5-fluorouracil.

The median overall survival in the study patients was 9.2 months for the Taxotere patients compared to 8.6 months for those on the standard regimen, while time to disease progression was 5.6 months in the Taxotere treatment arm vs. 3.7 months for the control group.

Source: United Press International

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