FDA OKs Drug for Head, Neck Cancer

Federal health officials expanded their approval of a Sanofi-Aventis SA injectable drug Wednesday to include treatment of head and neck cancer.

Taxotere, also called docetaxel, now may be used in combination with the chemotherapy drugs cisplatin and fluorouracil before radiation therapy for the treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck, the Food and Drug Administration said. This disease represents about 3 percent of all new cancer cases in the United States, the FDA said.

The FDA first approved Taxotere in 1996. It has been used to treat breast cancer, non-small cell lung cancer and prostate cancer.

In a clinical trial involving 358 patients with previously untreated and inoperable head and neck cancer, those treated with Taxotere in combination with cisplatin and fluorouracil survived longer _ 18.6 months versus 14.2 months, than those given the two other drugs alone, the FDA said. They also had a longer time to disease progression or death _ 11.4 months versus 8.3 months.

The most frequent adverse events reported by patients treated with Taxotere in the study were decreases in white and red blood cells, loss of hair, nausea and inflammation of the mouth and esophagus, the FDA said.

Sanofi-Aventis, based in France, is the world's third-largest pharmaceutical company.

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Food and Drug Administration: http://www.fda.gov/