Celgene Revlimid MDS filing
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Celgene is requesting a priority review for its Revlimid (lenalidomide) NDA for treatment of transfusion-dependent patients with myelodysplastic syndromes with a 5q deletion chromosomal abnormality. A rolling submission was completed April 8, the company said. The submission is based on a Phase II trial in patients with the 5q deletion abnormality. Revlimid has fast track designation for MDS as well as multiple myeloma. The firm's Thalomid (thalidomide) sNDA for use in multiple myeloma has been "approvable" since October 2004...