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FDA panel backs Revlimid

September 15, 2005 1:30 AM UTC

An FDA advisory committee voted in favor of approving Revlimid lenalidomide from Celgene (CELG) to treat myelodysplastic syndrome (MDS) in patients with 5q chromosomal deletions, even though most members said the single arm trial that served as the basis for the NDA was inadequate to characterize safety or to determine an optimal starting dose. The Oncologic Drugs Advisory Committee voted 10-5 to recommend approval, and 13-2 that CELG had failed to provide data that could serve as the basis for a recommended dose or to adequately describe the product's safety profile. ...