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news.Celgene Corporation has completed the rolling submission of its new drug application for Revlimid to the FDA for, seeking approval to market Revlimid as a treatment for patients with myelodysplastic syndromes.
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Celgene’s lead immunomodulatory drug (IMiD), Revlimid (lenalidomide), has received both orphan drug status and fast track designation from the FDA and orphan drug status from the EMEA for the treatment of myelodysplastic syndromes (MDS), a group of malignant blood cell disorders.
The new drug application (NDA) is seeking FDA approval to market Revlimid as a treatment for transfusion-dependent patients with MDS with a 5q deletion chromosomal abnormality.
The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5, 7, and 20 and 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.
In addition to this filing, Celgene is evaluating Revlimid in a broad range of hematology and oncology conditions, including multiple myeloma and solid tumor cancers.