Celgene Corporation announced that the Division of Oncology Drug Products at the US Food and Drug Administration (FDA) has accepted for review the company's Supplemental New Drug Application (sNDA) seeking approval to market Thalomid for the treatment of multiple myeloma. Multiple myeloma is the second most common blood cancer in the United States affecting approximately 50,000 people. About 14,600 new cases of multiple myeloma are diagnosed each year and about 11,000 Americans are expected to die each year of multiple myeloma.
The FDA approved Thalomid on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence. It not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
"Celgene appreciates the support from patients and clinical investigators who participated in these studies and we look forward to the FDA's action in the fall," said Sol Barer, chief operating officer of Celgene Corporation.
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 tumours. The cause of the disease is unknown. Multiple myeloma is the second most common cancer of the blood, representing approximately one per cent of all cancers and two per cent of all cancer deaths with a worldwide prevalence of approximately 200,000 cases. In the year 2002, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2002 was 57,370 worldwide.