FDA accepts MAA for Revlimid
The EMEA has accepted a marketing authorization application for the Thalidomide analogon Revlimid® submitted by Celgene Corp. (Summit, USA) for review. The application for the treatment 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 the orphan drug plus dexamethasone in multiple myeloma patients that have received at least one prior therapy. Interim analysis showed that both studies achieved the primary endpoint of time-to-disease progression with combination therapy of lenalidomide and dexamethasone. Due to its teratogenic potential, the drug can only be obtained through a special programme (RevAssist).