Revlimid Combination Granted Priority Review for Myeloma

SUMMIT, New Jersey—The FDA has given priority review status to Celgene Corporation's supplemental new drug application for lenalidomide (Revlimid) in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma. In two large phase III trials in previously treated myeloma patients, North American Trial MM-009 and International Trial MM-010, the combination showed safety and efficacy. Revlimid, a derivative of thalidomide (Thalomid), is an immunomodulatory drug. It previously received FDA approval for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndrome associated with a deletion 5q cytogenetic abnormality.