The European Medicines Agency (EMEA) has accepted for review Celgene Corporation's Marketing Authorization Application (MAA) for lenalidomide - Celgene Europe, submitted in February 2006.
The application 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 lenalidomide 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.
Revlimid has been designated as an Orphan Medicinal Product in the EU for the treatment of multiple myeloma (MM) and myelodysplastic syndromes (MDS). In September 2005, an MAA seeking authorization to market Revlimid as a treatment for low- to intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities was accepted by the EMEA and is currently under review.
"Celgene looks forward to working with the EMEA as it begins the review process for lenalidomide as a potential treatment for patients with relapsed or refractory multiple myeloma. We appreciate the efforts of all the people who made this filing possible, and acknowledge the commitment from all participants in these multiple myeloma studies, who helped lenalidomide get to this stage in the European regulatory process," said Graham Burton, Sr.VP, Regulatory Affairs and Pharmacovigilence for Celgene Corporation.