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news.New York-based ImClone Systems is planning to submit a supplemental Biologics License Application in the third quarter of 2005 to seek approval for the use of Erbitux in head and neck cancer.
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The announcement comes after the company held discussions with the FDA to determin possible future designations for Erbitux.
ImClone said it would conduct two clinical trails which would serve as the basis of the supplemental Biologics License Application (sBLA), together with other supportive data.
The first of these is a randomized, international phase III trial which will be carried out by ImClone Systems and Merck to examine the impact of combining Erbitux with radiation on locoregional control and overall survival in patients with locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN).
The second is a multicenter phase II trial conducted by Merck, which will aim to evaluate the response rate of Erbitux as a single agent in patients with advanced recurrent and/or metastatic SCCHN.