Revlimid NDA accepted by FDA
The FDA has formally accepted for review Celegene's New Drug Application (NDA) for Revlimid. The NDA is seeking approval as a targeted treatment for transfusion-dependent myelodysplastic syndromes (MDS) patients with deletion 5q chromosomal abnormality. A review date will be communicated to Celgene in approximately two weeks.
The FDA has formally accepted for review Celegene's New Drug Application (NDA) for Revlimid. The NDA is seeking approval as a targeted treatment for transfusion-dependent myelodysplastic syndromes (MDS) patients with deletion 5q chromosomal abnormality. A review date will be communicated to Celgene in approximately two weeks.
The NDA submission was based primarily upon the safety and efficacy results of a multi-center Phase II trial of 148 MDS patients with deletion 5q chromosomal abnormality and supplemented by supportive data from two additional MDS trials. 'We are pleased with the FDA filing of our Revlimid NDA, as a potential treatment for MDS patients with deletion 5q chromosomal abnormality,' said Dr Graham Burton, svp, regulatory affairs and pharmacovigilance.
About Revlimid
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. Revlimid affects multiple intracellular biological pathways.
About Myelodysplastic Syndromes
Myelodysplastic syndromes are a group of haematologic 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.