Merck KGaA announced has submitted an application to the European Medicines Agency (EMEA) to broaden the use of the targeted therapy Erbitux (cetuximab) to include 1st-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

The submitted label would extend the use of Erbitux for treatment of patients with recurrent and/or metastatic squamous cell cancer of the head and neck in combination with platinum-based chemotherapy.

The submission is supported by data from the Extreme study1 - ErbituX in 1st-line treatment of REcurrent or MEtastatic head and neck cancer - investigating the efficacy of Erbitux in combination with platinum-based chemotherapy in the 1st-line setting in patients with recurrent or metastatic SCCHN. The study showed that when added to current standard platinum-based chemotherapy, Erbitux significantly increased the overall survival time for patients.

"Erbitux represents a real breakthrough for the 1st-line treatment of head and neck cancer as it is the first treatment in more than 30 years to show a significant survival benefit," said Dr Wolfgang Wein, executive vice president, Oncology, Merck Serono. "If approved by the European Commission, this broader use of Erbitux would provide a new important treatment standard for patients with recurrent and/or metastatic head and neck cancer, an area where there is great clinical need".

The phase III randomized Extreme study involved 442 patients with previously untreated recurrent and/or metastatic SCCHN who were treated with either Erbitux plus platinum-based chemotherapy (cisplatin or carboplatin plus infusional 5-fluorouracil [5-FU]) or platinum-based 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 plus platinum-based chemotherapy compared to chemotherapy alone. The median overall survival for patients in the Erbitux plus platinum-based chemotherapy arm was 10.1 months; and 7.4 months for patients treated with platinum-based chemotherapy alone. This is among the longest ever reported survival times in a phase III trial for this patient population.

The toxicity profile of Erbitux in combination with platinum-based chemotherapy was manageable and consistent with the current safety information.

The application for the 1st-line indication will be reviewed by the Committee for Medicinal Products for Human Use (CHMP). If approved by the European Commission, patients within Europe may then start benefiting from Erbitux as a 1st-line treatment for recurrent and/or metastatic SCCHN.

Erbitux has been licensed in the European Union for use in combination with radiotherapy for locally advanced SCCHN since April 3, 2006. In addition, Erbitux was first approved for the treatment of metastatic colorectal cancer (mCRC) after irinotecan failure in Switzerland in December 2003 and in the European Union in June 2004. Merck was also recently granted a positive opinion by the CHMP to broaden the use of Erbitux for all lines of treatment for patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type mCRC in combination with chemotherapy.