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FDA Approves Taxotere for Head and Neck Cancer

Patients on Taxotere and chemotherapy survive 18.6 months, versus 14.2 months without Taxotere

WEDNESDAY, Oct. 18 (HealthDay News) -- The U.S. Food and Drug Administration has approved Taxotere (docetaxel) Injection Concentrate for advanced, inoperable head and neck cancer. Taxotere, made by Sanofi-Aventis, won approval for use with fluorouracil and cisplatin before radiotherapy.

The FDA approved Taxotere after a study of 358 patients with inoperable head and neck squamous cell carcinoma found that patients on docetaxel, fluorouracil and cisplatin survived 18.6 months, compared to 14.2 months for the non-docetaxel group. Docetaxel patients lived 11.4 months before disease progression or death, versus 8.3 months for non-docetaxel patients.

"Today's approval will provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival," Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement.

Common side-effects ranged from hair loss to nausea. Taxotere patients experienced more severe common side effects than the other patients, such as greater hair loss and decreased white blood cell counts, the FDA said.

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