FDA advisory committee recommends REVLIMID for approval for MDS patients

FDA Oncologic Drugs Advisory Committee Recommends REVLIMID(R) for Full Approval

By a 10-5 Vote, ODAC Recommends REVLIMID as Oral Targeted Therapy for Low to Intermediate-1-Risk MDS Patients With Deletion 5q Chromosomal Abnormality

WASHINGTON, Sept 14, 2005 /PRNewswire-FirstCall via COMTEX News Network/ -- Celgene Corporation (Nasdaq: CELG) announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) recommended full approval of REVLIMID (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. The committee based its recommendation on clinical data from an open label Phase II trial, evaluating REVLIMID in the largest trial with MDS patients with deletion 5q chromosomal abnormality to date. The data showed that:

• Approximately two-thirds of patients achieved resolution of chronic refractory anemia resulting in transfusion independence
• Response was associated with meaningful cytogenetic and bone marrow remission
• Responder median hemoglobin increased more than 5.0 grams per deciliter
• After median follow-up of 58 weeks, the median duration of transfusion-independence response had not yet been reached
• The dosing in the study was based on tolerability and additional studies are planned to refine dosing
• The major side effects were cytopenias leading to dose reductions

"We are excited about ODAC's positive recommendation for approval of this NDA. REVLIMID will offer the opportunity to improve the lives of deletion 5q MDS patients with limited therapeutic options beyond blood transfusions," said John W. Jackson, Chairman and Chief Executive Officer, Celgene Corporation.