The United States Food and Drug Administration (FDA) has approved Thalomid® (thalidomide) in combination with the steroid dexamethasone for the treatment of newly diagnosed multiple myeloma.
Multiple myeloma is a cancer of the blood that affects the plasma cells. Plasma cells are an important part of the immune system; they produce antibodies to help fight infection and disease. Multiple Myeloma is characterized by an excess production of abnormal plasma cells. Symptoms include increased risk of bacterial infections and impaired immune responses.
Myeloma may also damage the kidneys and cause osteoporosis, anemia, and an elevated blood calcium level.
Multiple myeloma is the second most common cancer of the blood in the United States. It affects approximately 50,000 individuals in the U.S., with about 14,600 cases diagnosed annually.
Thalomide is an immunomodulatory agent that helps the immune system fight cancer. In addition, Thalomid stops or prevents blood vessels from growing and providing cancer cells with nutrients and oxygen for their spread and growth.
The clinical trial prompting the new indication for Thalomid was a direct comparison of Thalomid plus dexamethasone to dexamethasone alone in the treatment of newly diagnosed multiple myeloma. Patients treated with Thalomid/dexamethasone had improved anticancer responses compared to those treated with dexamethasone alone.
Patients with newly diagnosed multiple myeloma may wish to discuss their individual risks and benefits of treatment with Thalomid with their physician.
Reference: Celgene. Thalomid(R) sNDA Granted FDA Approval for Treatment of Newly Diagnosed Multiple Myeloma. Available at: http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&t=Regular&id=861181&. Accessed May 2006.