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Keryx's cancer drug gets fast-track designation from FDA

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NEW YORK The Food and Drug Administration has granted fast-track review to an investigational drug by Keryx Biopharmaceuticals for cancer, Keryx announced Monday.

The FDA granted the status to KRX-0401 (perifosine), which prevents activation of a protein in an enzyme related to advanced colorectal cancer. The FDA Fast Track program is designed to help companies develop drugs that treat serious or life-threatening conditions and that are able to address unmet medical needs.

“We believe that this fast-track designation adds substantial value to perifosine’s development in refractory, advanced colorectal cancer,” Keryx CEO Ron Bentsur said in a statement.

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