Revlimid (lenalidomide) New Drug Application Accepted for Review by FDA
New Drug Application Based on Phase II Trial (MDS-003) in Myelodysplastic Syndromes Patients with Deletion 5q Chromosomal Abnormality
SUMMIT, N.J., June 7, 2005 -- Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has formally accepted for review the Company's New Drug Application (NDA) for Revlimid. The Revlimid NDA is seeking approval as a targeted treatment for transfusion-dependent myelodysplastic syndromes (MDS) patients with deletion 5q chromosomal abnormality. Review milestones will be communicated to Celgene in approximately two weeks.
The NDA submission was based primarily upon the results of a multi-center Phase II trial of 148 MDS patients with deletion 5q chromosomal abnormality. The data were recently presented during a plenary session at the May 2005 meeting of the American Society of Clinical Oncology.
"We are pleased with the FDA filing of our Revlimid NDA, as a potential treatment for MDS patients with deletion 5q chromosomal abnormality," said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and VP, Medical Affairs of Celgene Corporation.
Revlimid is a member of a new class of novel immunomodulatory drugs, or IMiDs(R). Celgene is evaluating treatments with Revlimid for a broad range of hematology and oncology conditions, including; multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes, chronic lymphocytic leukemia, as well as solid tumor cancers. Revlimid affects multiple intracellular biological pathways. The pipeline of IMiDs, including Revlimid, is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of-matter and use patents.
Revlimid is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
About Myelodysplastic Syndromes
Myelodysplastic syndromes are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or "blast" stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. According to the American Cancer Society, 10,000 to 20,000 new cases of MDS are diagnosed each year in the United States, with mean survival rates ranging from approximately six months to six years for the different classifications of MDS. MDS patients must often rely on blood transfusions to manage symptoms of anemia and fatigue until they develop life-threatening iron overload and/or toxicity, thus underscoring the critical need for new therapies targeting the cause of the condition rather than simply managing its symptoms.
About Deletion 5q Chromosomal Abnormality
Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with myelodysplastic syndrome, and involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5, 7, and 20. Another common abnormality is an extra copy of chromosome 8. A deletion involving the 5q chromosome may be involved in 20 to 30% of all MDS patients. The World Health Organization has also recently identified a unique subset of MDS patients with a "5q- Syndrome" where the only chromosomal abnormality is a specific portion of the 5q chromosome.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Celgene website.
Posted: June 2005
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- FDA and Celgene Revlimid Briefing Documents for Advisory Committee Meeting Available Online - September 13, 2005
- FDA Grants Priority Review for Revlimid NDA for Treatment of Low- and Intermediate- Risk MDS With Deletion 5q Chromosomal Abnormality - June 21, 2005
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