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Article: FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia.
- Article from:
- PR Newswire
- Article date:
- September 20, 2007
CopyrightCOPYRIGHT 2007 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Study Data Demonstrated Improved Progression-free Survival with Campath
CAMBRIDGE, Mass. and WAYNE, N.J., Sept. 20 /PRNewswire-FirstCall/ -- Genzyme Corp. and Bayer HealthCare Pharmaceuticals Inc. 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 ...