FDA Grants Priority Review for Revlimid NDA for Treatment of Low- and Intermediate- Risk MDS With Deletion 5q Chromosomal Abnormality
SUMMIT, N.J., June 21, 2005 -- Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has granted a Priority Review designation to its New Drug Application (NDA) for Revlimid with a Prescription Drug User Fee Act (PDUFA) date by October 7, 2005. The Company is seeking approval to market Revlimid as a targeted treatment for transfusion-dependent patients with low- and intermediate-risk myelodysplastic syndromes (MDS) with deletion 5q chromosomal abnormality. Priority Review is granted to a pharmaceutical product that, if approved, would be a significant improvement compared to existing marketed products or approved therapies in the treatment, diagnosis, or prevention of a disease. It is the expectation of the Company that the application will be reviewed at an Oncology Drug Advisory Committee (ODAC) meeting in September. NDAs with priority review receive expedited treatment, with the target review period for the application reduced from ten months to six months.
The NDA submission was based primarily upon the safety and efficacy results of an open-label, multi-center Phase II study of low- and intermediate-risk myelodysplastic syndromes (MDS) patients with deletion 5q chromosomal abnormality (MDS-003), and supplemented by supportive data from two additional MDS trials. The MDS-003 data were recently presented during a plenary session at the May 2005 meeting of the American Society of Clinical Oncology.
The Celgene clinical and regulatory management team has been further strengthened by the addition of Robert J. DeLap, M.D., Ph.D., as Vice President of Global Medical Research reporting to Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and Vice President of Medical Affairs for Celgene. Dr. DeLap has extensive medical and scientific background, and a broad range of experience in academic medicine, pharmaceutical drug development, and regulatory affairs. His prior experience has included several years at the U.S. Food and Drug Administration, where he served as Director of the Division of Oncology Drug Products and later was Director of the Office of Drug Evaluation V in FDA's Center for Drug Evaluation and Research. He has also held senior positions in drug development and regulatory affairs, at other major pharmaceutical companies, and was on the faculty of the Georgetown University School of Medicine.
Revlimid, an IMiD(R) immunomodulatory drug, represents an innovative approach in addressing unmet medical needs in cancer and immune-inflammatory diseases. Celgene currently 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 syndromes, 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 Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval - September 14, 2005
- FDA and Celgene Revlimid Briefing Documents for Advisory Committee Meeting Available Online - September 13, 2005
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