Celgene's Revlimid MMA accepted by EMEA

US firm Celgene Corp says that the European Medicines Agency (EMEA) has accepted for review the its Marketing Authorization Application Revlimid (lenalidomide), 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 prespecified 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.

Revlimid has been designated as an Orphan Medicinal Product in the European Union for the treatment of multiple myeloma and myelodysplastic syndromes.