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FDA grants REVLIMID NDA approval

Celgene Corporation (NASDAQ: CELG) announced that the U.S. Food and Drug Administration (FDA) granted approval of REVLIMID (lenalidomide) which is indicated 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. REVLIMID will be available through a REVLIMID Education and Prescribing Safety Program, called RevAssistsm via contracted pharmacies.

"The clinical data from a Phase II trial of 148 patients demonstrated that Revlimid can reduce or even eliminate the need for transfusions in many patients with del 5q MDS," said Dr. Alan List, Professor of Oncology and Medicine, and Chief Division of Hematologic Malignancies Hematologic Malignancies at H. Lee Moffitt Cancer Center, Tampa, Florida, and the study's lead investigator. "I am extremely pleased with the FDA's action today."

The safety profile for REVLIMID has shown that neutropenia and/or thrombocytopenia were the most common adverse event (AE) and that patients may require a dose adjustment. Other observed and common AE's include diarrhea, pruritis, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp, dyspnea, and pharyngitis.

"Being able to use an oral therapy such as REVLIMID to treat del 5q MDS could reduce or even eliminate the need for red blood cell transfusions in MDS patients," said Dr. John Bennett, Professor of Oncology in Medicine, Pathology, and Laboratory Medicine, University of Rochester.

"The FDA approval of REVLIMID offers a new therapeutic option to this particular group of patients with myelodysplastic syndromes," said Graham Burton, M.D., SVP, Regulatory Affairs and Pharmacovigilance for Celgene.

The timing of this approval will result in most initial shipments of REVLIMID to be d
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Contact: Brian P. Gill
908-673-9530
Weber Shandwick Worldwide
28-Dec-2005


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