FDA Approves Revlimid for Myeloma Rx

•ROCKVILLE, Maryland—The FDA has approved Celgene's Supplemental New Drug Application for Revlimid (lenalidomide) in combination with dexamethasone (Rev/Dex) for the treatment of multiple myeloma patients who have received at least one prior therapy. Revlimid, an immunomodulatory drug and thalidomide analog, was initially approved for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality.

The Revlimid approval was based on results of two large randomized pivotal phase III trials, the North American Trial MM-009 and the International Trial MM-010. Both trials showed significant improvements in time to progression with Rev/Dex vs Dex/placebo in previously treated multiple myeloma patients.

Recently, overall survival results have been reported for both trials. Data from MM-009 reported at the ASCO 2006 annual meeting in Atlanta showed a significant improvement in overall survival with Rev/Dex vs Dex/placebo (29.6 months vs 20.2 months, P < .0001). At the 11th Congress of the European Hematology Association, MM-010 researchers reported that median overall survival had not been reached for Rev/Dex vs 20.6 months for Dex/placebo (P = .03).