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Home Industry News Bayer drug ‘more effective than chlorambucil’

Bayer drug ‘more effective than chlorambucil’

10th April 2007

Bayer HealthCare and Genzyme have reported that Campath (alemtuzumab), a treatment for B-Cell chronic lymphocytic leukaemia (B-CLL), exhibited improved efficacy with a manageable safety profile when compared to chlorambucil.

Campath is currently indicated as a treatment for patients who have failed fludarabine therapy that have been treated with an alkalyting agent. The firms have made a submission to the US Food and Drug Administration to expand the labelling of the product to include first line treatment of B-CLL patients, with a similar submission to European authorities to be made in the coming weeks.

Gunnar Riemann, a board member of Bayer Schering Pharma, said: “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.”

He added that the company would also be seeking approval from regulatory bodies for a formulation of the compounds suitable for administration by subcutaneous injection.

Genyzme reported that the application for an expanded label for the compounds was based on evidence from a phase III clinical study showing that Campath exhibited improved efficacy with a controlled safety profile compared to chlorambucil, with the label expansion broadening the use of the drug in treating patients with leukaemia.

Last December, Genzyme reported that patients administered with Campath for up to 12 weeks attained a median period of two years before further treatment was required.

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