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Docetaxel (Taxotere Injection Concentrate, Sanofi-Aventis), combined with cisplatin and 5-fluorouracil (5-FU), is now approved for induction therapy of locally advanced squamous cell carcinoma of the head and neck before patients undergo chemoradiotherapy and surgery.
The FDA based its approval on the results of a phase 3 randomized, openlabel, international trial (TAX 324) that established the efficacy and safety of the docetaxel-based regimen in significantly improving survival.
Docetaxel is also indicated for patients with breast cancer, non-small cell lung cancer, and prostate cancer.
(Source: Sanofi-Aventis, October 1, 2007.)
