SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced it was notified by the U.S. Food and Drug Administration (FDA) that there will not be an Oncologic Drugs Advisory Committee (“ODAC”) meeting scheduled for November 8, 2012. The agency has informed the Company the review of its new drug application (“NDA”) for pomalidomide is continuing with the previously announced Prescription Drug User Fee Act (PDUFA) action date remaining Feb. 10, 2013. The Company is seeking approval to market pomalidomide in combination with dexamethasone as a potential treatment for patients with relapsed and refractory multiple myeloma that has progressed following at least two prior therapies.
Pomalidomide is not approved in the U.S. for the treatment of multiple myeloma.
Pomalidomide is an IMiDs® compound. Pomalidomide and other IMiDs compounds continue to be evaluated in over 100 clinical trials. The IMiDs compound pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company’s Web site at www.celgene.com.
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Source: Celgene Corporation