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news.US biotech firm Celgene Corporation has had its new drug application for Revlimid, a treatment for transfusion-dependent myelodysplastic syndromes, formally accepted for review by the FDA.
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Approval is sought for the use of Revlimid to treat myelodysplastic syndrome (MDS) patients with deletion 5q chromosomal abnormality. FDA review milestones will be communicated to Celgene in approximately two weeks.
The application was based primarily upon the results of a multi-center phase II trial of 148 MDS patients with deletion 5q chromosomal abnormality.
Revlimid is a member of a new class of novel immunomodulatory drugs, or IMiDs. 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. Revlinid affects multiple intracellular biological pathways. The pipeline of IMiDs, including Revlimid , is covered by a comprehensive intellectual property estate of US 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.
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 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 immature 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 US, with mean survival rates ranging from approximately six months to six years for the different classifications of 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.