German drugmaker Merck KGaA said it has received a positive recommendation from the European Medicines Agency drug advisory panel to extend the indications of its Erbitux drug to include the treatment of locally-advanced head and neck cancer.
The EMEA’s Committee for Medicinal Products for Human use agreed to back the new labelling on Friday. Erbitux is already approved in the EU for metastatic colon cancer, adding 218 million euros ($258m) to the German firm’s coffers last year,
The application is based on the results of a Phase III international study which suggested that Erbitux, when given in combination with radiotherapy prolonged median-survival time by 19.7 months.
Around 100,800 people in Europe are diagnosed with head and neck cancer every year, with nearly 40,000 dying from the disease. Merck received its first approval for this indication, in Switzerland, last December.
The German drugmaker has also completed recruitment in three Phase III clinical trials of Erbitux in several cancer types, including the second-line treatment of advanced colon cancer, the first-line treatment of recurrent and head and neck cancer and the first-line treatment of non-small cell lung cancer. Approval in these cancers could quickly elevate Erbitux to blockbuster status.
Merck licensed the right to sell Erbitux outside the US and Canada from biotechnology company ImClone Systems in 1998. ImClone's North American partner is Bristol-Myers Squibb, which recorded sales of $418 million from Erbitux in 2005.