Merck KGaA applies to extend EMEA indication for Erbitux

German drug and chemicals firm Merck KGaA has submitted an application to the European Medicines Agency (EMEA) to broaden the use of its Erbitux (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based chemotherapy.

The submission is supported by data from the Phase III randomized EXTREME study, involving 442 patients with previously-untreated recurrent and/or metastatic SCCHN who had received either Erbitux plus platinum-based chemotherapy (cisplatin or carboplatin plus infusional 5-fluorouracil) or chemotherapy alone.

The study met the primary endpoint of significantly increasing overall survival. An improvement of 2.7 months was seen for patients treated with Erbitux compared to chemotherapy alone. The median overall survival for patients in the Erbitux arm was 10.1 months; and 7.4 months for patients treated with platinum-based chemotherapy alone. Findings from the EXTREME study were presented at the American Society of Clinical Oncology congress in June 2007 and at the European Congress of Clinical Oncology in September 2007.