Genzyme Submits sBLA for Campath as First-Line B-CLL Treatment

Genzyme and Bayer HealthCare have announced that a supplemental biologics license application (sBLA) for Campath has been submitted to the FDA to expand the current product label to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL).

Campath (alemtuzumab) is currently approved for the treatment of B-CLL patients who have been previously treated with an alkylating agent and have failed fludarabine therapy. Genzyme said it 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 U.S. as MabCampath by Bayer Schering Pharma and in the U.S. by Bayer HealthCare Pharmaceuticals as Campath. A label expansion to include first-line therapy would significantly increase the number of potential patients for whom Campath would be indicated, the companies said.

The sBLA is based on positive data from a Phase III clinical trial that showed first-line treatment of B-CLL with Campath resulted in significantly better efficacy with a manageable safety profile as compared with treatment with chlorambucil.

The study was an international, randomized, controlled clinical trial conducted to satisfy a postapproval commitment to the FDA to demonstrate the clinical benefit of Campath in B-CLL.