The US FDA has granted a Priority Review designation to Celgene Corporation's 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.

According to the company release, 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.