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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