Taxotere combination approved for induction therapy in SCCHN

October 1, 2007

FDA has approved Sanofi-Aventis' Taxotere (docetaxel) for use in combination with cisplatin and fluorouracil (TPF) for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN)

ROCKVILLE, Maryland—FDA has approved Sanofi-Aventis' Taxotere (docetaxel) for use in combination with cisplatin and fluorouracil (TPF) for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

FDA based its approval on TAX- 324, a multicenter, open-label, randomized trial of 501 patients. Overall survival was significantly prolonged with the Taxotere-containing regimen, compared with PF alone (P = .0058). Median survival was 70.6 months in the TPF group vs 30.1 months in the PF group (HR 0.70).