Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has granted a Priority Review designation to its Supplemental New Drug Application (sNDA) for REVLIMID (lenalidomide) for the treatment of relapsed or refractory multiple myeloma.
The Prescription Drug User Fee Act (PDUFA) date is June 30, 2006. The Company is seeking approval to market REVLIMID in combination with dexamethasone as a proposed indication for the treatment of multiple myeloma patients who have received at least one prior therapy subject to FDA review and approval. Priority Review is granted to a pharmaceutical product that, if approved, would be a significant improvement compared to existing marketed products or approved therapies in the treatment, diagnosis, or prevention of a disease.
The REVLIMID sNDA submission is based upon the safety and efficacy results of two large randomized pivotal Phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating REVLIMID plus dexamethasone in multiple myeloma patients that have received at least one prior therapy. Based on a pre-specified interim analysis, both studies achieved the primary endpoint of time to disease progression (TTP) with combination therapy of lenalidomide and dexamethasone over that of placebo and dexamethasone. The clinical data, both from MM-009 and MM-010, were presented during a plenary session at the December 2005 meeting of the American Society of Hematology (ASH).
The Celgene Expanded Access Program, available to qualified patients with relapsed or refractory multiple myeloma, will remain open to ensure broad access to REVLIMID while the REVLIMID sNDA is under review by the FDA.