Taxotere gets fast track status for head and neck cancer indication

BRIDGEWATER, New Jersey—Sanofi-aventis has received priority review from the FDA for its supplemental New Drug Application for Taxotere (docetaxel) in combination with cisplatin and fluorouracil for induction (neoadjuvant) therapy of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) prior to chemoradiotherapy and surgery. The combination is currently approved for induction therapy of inoperable advanced SCCHN. The submission is based on the TAX 324 phase III study showing significantly improved overall survival in patients treated with the Taxotere combination vs cisplatin/fluorouracil alone.