Bayer's MabCampath cleared for CLL by EC

Bayer Schering Pharma AG, part of Germany's Bayer, says that the European Commission has expanded marketing approval for the monoclonal antibody product MabCampath (alemtuzumab) to include its use in the treatment of B-cell chronic lymphocytic leukemia. Specifically, the commission has cleared the agent for CLL sufferers for whom fludarabine chemotherapy is not appropriate.

The decision is based on data from the CAM307 study, an open-label Phase III program that compared MabCampath with chlorambucil in treatment-naive B-CLL patients. The results showed that MabCampath reduced risk of disease progression and death by 42%, versus the comparator. In addition, treated subjects demonstrated higher overall and complete response rates and experienced extended therapy-free periods, compared with those in the study group that received chlorambucil.

Last year in the USA, where the product is sold as Campath, the Food and Drug Administration approved a similar labeling extension, clearing the product as a single agent drug for B-CLL patients (Marketletter October 1, 2007).