Genzyme and Bayer Get New Campath Approval

Genzyme and Bayer HealthCare Pharmaceuticals have reported that the FDA has approved a supplemental biologics license application for Campath and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia.

Peter Hillmen, lead investigator of the pivotal study comparing Campath against chlorambucil said: “Campath is clearly an important single agent for the first-line treatment of chronic lymphocytic leukemia (CLL). We are excited to be entering an era where our improved understanding of CLL, coupled with more advanced laboratory tests and targeted therapy options like Campath, have dramatically changed the first-line treatment approach for this type of leukemia.”

According to the companies, Campath works in an entirely different way than chemotherapy, and is the first and only monoclonal antibody approved by the FDA for the treatment of B-cell chronic lymphocytic leukemia (B- CLL).

Mark Enyedy, president oncology business unit of Genzyme said: “The data that supported this label expansion add to a growing body of evidence about the effectiveness of Campath across the entire B-CLL treatment pathway. A broader range of patients is now eligible for Campath treatment, regardless of whether they have received prior therapy.”