EMA concludes Revlimid provides positive treatment for Multiple Myeloma

The EMA has confirmed that the benefit-risk balance for Revlimid (lenalidomide), from Celgene, used in combination with dexamethasone to treat adults with Multiple Myeloma remains positive. However it also advises of the risk of new cancers as a result of treatment. This review follows the results of three new studies which show a four-fold increase in new cancers (including solid tumours and cancers of the blood and the immune system) in patients with newly diagnosed Multiple Myeloma who were treated with Revlimid and received other treatments concomitantly. These studies were carried out in patients for whom Revlimid is not currently indicated, but the CHMP was concerned that the results could also be relevant for the approved patient population. It concluded that the benefits of Revlimid, particularly improved survival, continue to outweigh the risks but recommended that the prescribing information for Revlimid be updated with a warning and advice to doctors on the risk of new cancers.