Celgene's Revlimid gets FDA priority review

USA-based Celgene says that the Food and Drug Administration has granted a priority review designation to its supplemental New Drug Application for Revlimid (lenalidomide) for the treatment of relapsed or refractory multiple myeloma. The Prescription Drug User Fee Act date is June 30. 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.

The Revlimid sNDA submission is based on 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 the compound 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 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.