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ASCO In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Celgene Revlimid MDS data: Celgene's immunomodulatory drug Revlimid (lenalidomide) achieved a 70% cytogenetic response rate in a pivotal, Phase II trial (MDS-003) including 148 patients with 5q deletion myelodysplastic syndromes, the company reports May 15 at the American Society of Clinical Oncology meeting in Orlando, Fla. The firm notes that 66% of the 146 patients who were transfusion dependent at baseline achieved transfusion independence and a median hemoglobin increase of 5.3 g/dL. Investigators concluded that lenalidomide has "unprecedented hematologic and [cytogenetic] remitting activity." Celgene completed a rolling submission of its Revlimid NDA for MDS patients with the 5q abnormality in March; a priority review is expected...

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