CORRECTED - US FDA panel votes in favor of Glaxo, Genmab drug

Fri May 29, 2009 2:53pm EDT
 
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(Removes second-paragraph reference to vote abstention)

ORLANDO, Fla., May 29 (Reuters) - A small trial of Arzerra, which is being developed by GlaxoSmithKline PLC (GSK.L) and Genmab (GEN.CO) for treating chronic lymphocytic leukemia, is sufficient for the U.S. Food and Drug Administration to approve the drug, an advisory committee to the agency said on Friday.

The panel voted 10-3 that the trial results were likely to predict clinical benefit.

"I am impressed by the resolution of symptoms," said Dr. Margaret Tempero, deputy director at the University of California at San Francisco's cancer center. "I also thought the overall survival benefit looked encouraging."

Glaxo and Genmab are seeking accelerated approval of Arzerra, based on results from a small trial that did not include a comparison arm.

Initially, the companies are seeking approval for CLL patients who have failed two other treatments -- fludarabine and alemtuzumab -- and others who have failed fludarabine and for whom alemtuzumab, sold by Genzyme (GENZ.O) as Campath, was inappropriate because of their bulky tumors.

 

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