Following a priority review of a supplemental new drug application, the FDA has approved docetaxel (Taxotere Injection Concentrate, Sanofi-Aventis) in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck.
This approval marks the 10th indication for Taxotere (the seventh in the U.S.).
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Head and neck cancer usually begins in the cells that line the mucosal surfaces in the mouth, nose, and throat. The term “head and neck” encompasses the oral cavity, salivary glands, paranasal sinuses, nasal cavity, pharynx, larynx, and lymph nodes in the upper part of the neck.