Erbitux produces survival benefit in head and neck cancer

The study demonstrated that the addition of the drug to radiation resulted in a 9.5 month improvement in median duration of locoregional control, or the prevention of the spread of cancer beyond the head and neck region, and a 19.7 month improvement in median survival when compared to radiation alone; both results were statistically significant.

The median overall survival with radiation plus Erbitux was 49 months versus 29.3 months for radiation alone. In addition, there was an advantage for the Erbitux regimen over radiation alone in the three year survival rates.

With the exception of acneiform rash and infusion reactions, the incidence of grade three or greater toxicity, including mucositis, which often precludes combining chemotherapies with radiation, did not differ significantly between the treatment arms.

“Radiation therapy or radiation therapy combined with chemotherapy are the principal treatment options in this disease type,” said Dr James Bonner, University of Alabama, principal investigator for the study. “If approved, Erbitux added to radiation may represent an alternative treatment option for patients with head and neck cancer.”

The company has filed for marketing approval for the drug in the US and has been granted priority review by the FDA, meaning that the FDA has until March 1st 2006 to make a decision on the drug in this indication. ImClone’s European partner Merck KGaA has submitted similar filings in Europe. The drug is already licensed for the treatment of colorectal cancer.