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Title: Cetuximab Approved for First-Line Treatment of Head and Neck Cancer in Europe
 "Cetuximab Approved for First-Line Treatment of Head and Neck Cancer in Europe"


NEW YORK -- December 1, 2008 -- The European Commission has approved a new indication for the use of cetuximab (Erbitux) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The approval is based primarily upon the results of the Erbitux in First-Line Treatment of Recurrent or Metastatic Head and Neck Cancer (EXTREME) study, published in the September issue of the [New England Journal of Medicine.

    The EXTREME study established that adding cetuximab to platinum-based chemotherapy significantly prolonged median overall and progression-free survival, and also significantly increased response rate.

    Patients treated with cetuximab plus chemotherapy experienced the following improvements, compared with chemotherapy alone:
    · Median overall survival increase of nearly 3 months (10.1 vs 7.4 months; P = .04), equating to a 20% reduction in the risk of death (hazard ratio [HR]: 0.80) during the study period
    · 70% increase in median progression-free survival (5.6 vs 3.3 months; P < .001)
    · 80% relative increase in response rate (36% vs 20%; P < .001)

    The most commonly reported side effect with cetuximab is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with cetuximab; about half of these reactions are severe.

    SOURCE: Merck





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