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The IMF Advocates Formal Approval of Thalomid(R) for Myeloma
The Foundation Supports Thalomid (Thalidomide) as a 'Standard of Care' That Extends and Improves the Quality of Life of Myeloma Patients

NORTH HOLLYWOOD, Calif., Nov. 15 /PRNewswire/ -- The International Myeloma Foundation -- supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians -- today expressed disappointment in the decision by the Food and Drug Administration to further delay formal approval of thalidomide for the treatment of myeloma. Based on extensive clinical data, Thalidomide, marketed under the brand name Thalomid(R) by the Celgene Corporation, is the most widely prescribed treatment for myeloma even though it has not been formally approved for use in cancer. Myeloma, also called multiple myeloma, is a potentially lethal bone marrow cancer that affects blood cell production causing fatigue, weakness, and pain. It is the second most common blood cancer after lymphomas, affecting more than 250,000 people worldwide.

"Thalidomide remains one of the most important drugs we have for the treatment of myeloma, and while we are encouraged by promising new treatments, thalidomide is clinically proven with a track record supported by clinical data from studies in the U.S. and Europe," said Susie Novis, president of the International Myeloma Foundation. "On behalf of our patients and their families, the International Myeloma Foundation will continue to support formal approval of this important therapy for patients fighting this life threatening cancer."

The FDA today told Celgene that it will require additional patient information, safety information and revisions to the drug's labeling before issuing a formal marketing approval for use in multiple myeloma.

Although thalidomide was associated with birth defects in its early history when it was prescribed as a sedative specifically for pregnant women, it has shown promise in treating both blood cancers and solid tumors. Its distribution is carefully controlled by a patented mandatory program called S.T.E.P.S.(R) to help ensure it will not be used by women during pregnancy.

"This is a drug I rely on for my myeloma patients both as an initial treatment and for patients who have relapsed after other treatments," said Brian G. M. Durie, M.D., chairman of the International Myeloma Foundation and a practicing hematologist/oncologist. "As demonstrated in multiple clinical studies, I find that thalidomide in combination with the steroid dexamethasone does an excellent job of controlling symptoms and delaying disease progression in many of my patients, while the side effects are easily managed. Thalidomide's use is supported by clinical data and clinical practice, and we will work with the FDA to ensure continuing access to this important drug for our patients."

Thalidomide is formally approved by the FDA only for a side effect of leprosy. However its use as first line therapy in myeloma is supported by the authoritative National Comprehensive Cancer Network Clinical Practice Guidelines and it is also being studied in a wide range of cancers.

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