Genzyme applies for expanded Campath label

Campath is currently approved for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been previously treated with an alkylating agent and have failed fludarabine therapy. Genzyme intends to make a similar filing in Europe within the next couple of weeks to support this label expansion.

The product is marketed outside the US as MabCampath, by Bayer Schering Pharma and in the US by Bayer HealthCare Pharmaceuticals, as Campath. The companies believe that a label expansion to include first-line therapy would significantly increase the number of potential patients for whom Campath would be indicated.

“Submission of this sBLA is based on positive data from a phase III clinical trial, which showed first-line treatment of B-CLL with Campath resulted in significantly better efficacy with a manageable safety profile as compared to chlorambucil,” stated Mark Enyedy, senior vice-president of Genzyme's oncology business unit.

“In addition to the filing to expand the product's label, we will continue focusing our efforts on further exploring the full potential of Campath in high risk CLL, combination and consolidation therapy, and in seeking approval for treatment via subcutaneous administration,” stated Gunnar Riemann, member of the Board Management of Bayer Schering Pharma, Germany.