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FDA Issues Approvable Letter for Thalidomide's New Drug Application

SUMMIT, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) today announced the U.S. Food and Drug Administration (FDA) issued an approvable letter in response to the Company's sNDA for multiple myeloma (MM). The FDA has requested revised product labeling with the specific indication of newly diagnosed multiple myeloma and updated safety information, as well as some additional patient information to finalize its review.

The THALOMID sNDA is based on results from a large Phase III randomized Eastern Cooperative Oncology Group (ECOG) study comparing thalidomide plus dexamethasone to dexamethasone alone in previously untreated multiple myeloma patients.

"Based on ongoing discussions with the FDA we expect to complete our responses to these requests quickly," said Graham Burton, M.D., SVP, Regulatory Affairs and Pharmacovigilance for Celgene.

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 immuno- globulin 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.

Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a reported worldwide prevalence of approximately 200,000 cases. In the year 2004, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2005 is about 60,000 worldwide.

Source: Celgene Corporation

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