FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adul...( Study Data Demonstrated Improved Pr...)

Study Data Demonstrated Improved Progression-free Survival with Campath

CAMBRIDGE, Mass. and WAYNE, N.J., Sept. 20 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) and Bayer HealthCare Pharmaceuticals Inc. (NYSE: BAY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for Campath(R) (alemtuzumab) and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath was initially approved in 2001 under accelerated approval regulations and the FDA has determined that the study results submitted in the sBLA fulfill the post- marketing commitment to verify clinical benefit. A label expansion is under consideration in Europe.

"Campath is clearly an important single agent for the first-line treatment of CLL," said Peter Hillmen, MB, ChB, of the Leeds General Infirmary, Leeds, United Kingdom, and the lead investigator of the pivotal study comparing Campath against chlorambucil. "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."

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- CLL.

"The data that supported this label expa
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