US FDA clears Celgene's Revlimid for MM

USA-based drugmaker Celgene says that the Food and Drug Administration has approved Revlimid (lenalidomide) for multiple myeloma, the country's second most common blood cancer, affecting 50,000 US citizens.

The agency approved Celgene's supplemental New Drug Application for the drug in combination with dexamethasone as a treatment for MM patients who have received at least one prior therapy. The novel immunomodulator is already cleared for the treatment of transfusion-dependent anemia due to low-or-intermediate-1-risk myelodysplastic syndromes associated with a 5q deletion cytogenetic abnormality, with or without additional abnormalities.

According to Celgene, the thalidomide analog's approval is supported by data presented at the 2005 meeting of the American Society of Clinical Oncology showing double the efficacy and five times the complete remission rate compared to standard therapy, as well as delayed MM progression in relapsed or refractory patients for nearly one a year, a significant benefit considering that the disease currently has a four-year survival rate.