CHMP requires more data for Revlimid (Celgene) application for maintenance therapy in Multiple Myeloma

Celgene has decided to withdraw the new indication submission to the Committee for Medicinal Products for Human Use (CHMP) for Revlimid (lenalidomide), which was intended for the maintenance treatment of newly diagnosed Multiple Myeloma patients who have not progressed following initial treatment with melphalan, prednisone and Revlimid (lenalidomide), or maintenance therapy following autologous stem cell transplantation. In response to the CHMP's request, Celgene plans to re-submit with more mature data, which allows CHMP to conclude a clear benefit/risk ratio