Bayer announces European approval of MabCampath

Bayer has announced that MabCampath (alemtuzumab) has been granted marketing authorisation by the European Commission as a treatment for patients with B-Cell chronic lymphocytic leukemia (B-CLL) where the use of fludarabine combination chemotherapy has been deemed inappropriate.

The compound has been jointly developed by Bayer Schering Pharma and Genzymem, with Bayer holding the exclusive marketing and distribution rights to the drug worldwide.

It has a different mode of operation to chemotherapy, instead working by targeting CD52 found on B cells and binding itself to this antigen, causing the immune system to destroy only these targeted cells.

MabCampath has received extended marketing authorisation from the European Commission following the CAM307 phase III clinical study that compared the compound to chlorambucil in untreated B-CLL patients.

Peter Hillmen, of the Leeds General Infirmary, said: “The data supporting this marketing authorisation showed that MabCampath produced a higher response rate than that seen in patients with chronic lymphocytic leukaemia for any single agent in previous front-line trials.”

He added that the compound could potentially become a vital treatment option for B-CLL patients in Europe for whom the administration of fludarabine combination chemotherapy is not recommended.

In June 2006, Schering announced that MabCampath is a safe and effective first line treatment for B-CLL patients, including those with a poor prognosis.