FDA Approves Thalomid For Multipple Myeloma Therapy

Filed in archive Drugs, Vaccines and Therapeutics on May 30, 2006

Thalomid (generic: thalidomide) is a drug manufactured by Celgene, Inc, for the treatment of certain symptoms associated with Erythema Nodosum Leprosum (ENL). It is an inhibitor of tumor necrosis factor alpha, and is the best known agent for short-term treatment of ENL skin manifestations, as well as postremission maintenance therapy to prevent recurrence.

Celgene announced however that it has found a new application for Thalomid and that the US FDA has granted its Supplemental New Drug Application for the use of Thalomid in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma, a common type of blood cancer affecting about 50,000 patients in the US.

THALOMID is available through a THALOMID Education and Prescribing Safety System, called S.T.E.P.S.(R). Through the use of our S.T.E.P.S. program, more than 130,000 U.S. patients have had safe access to THALOMID since its market introduction in July 1998. This FDA approval for the indication of THALOMID in the treatment of newly diagnosed multiple myeloma allows physicians and their patients to be treated with another therapy option for this incurable blood cancer.

The safety profile of Thalomid has shown quite a number of side effects, ranging from constipation to thrombosis and edema. For more information, see the Thalomid website or the Celgene Press Release.