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Article: FDA approves Campath as single agent for B-CLL.
- Article from:
- Pharma Marketletter
- Article date:
- October 1, 2007
CopyrightCOPYRIGHT 2007 Marketletter Publications Ltd. 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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Bayer Schering Pharma, the pharmaceutical arm of Germany's Bayer AG, and US biotechnology major Genzyme say that the Food and Drug Administration has approved a supplemental Biologics License Application for the anticancer agent Campath (alemtuzumab). The agency has cleared the drug as a single-agent therapy for the treatment of B-cell chronic adult lymphocytic leukemia.
The FDA's decision is based on data from a Phase III trial, presented at last year's American Society of Hematology conference in Orlando, Florida (Marketletters passim). The results ...