Merck Serono extends Erbitux indication

Merck Serono, the pharmaceuticals division of Germany's Merck KGaA, has received approval from the European Commission to extend the use of its Erbitux (cetuximab) to include the 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 EXTREMEa study, published in the New England Journal of Medicine in September. The EXTREME program established that adding Erbitux to platinum-based chemotherapy significantly prolonged median overall and progression-free survival, and also significantly increased response rate.

Patients treated with Erbitux plus chemotherapy experienced improvements compared to chemotherapy alone, including: a median overall survival increase of nearly three months (10.1 versus 7.4 months; p=0.04), equating to a 20% reduction in the risk of death (HR: 0.80) during the study period; a 70% increase in median progression-free survival (5.6 vs 3.3 months; p<0.001); and an 80% relative increase in response rate (36% vs 20%; p<0.001).