Additional Relevant Details The regulatory submission for daratumumab is supported by data from two Phase 3 studies:  The CASTOR (MMY3004) clinical study which showed daratumumab in combination with bortezomib and dexamethasone reduced the risk of disease progression or death by 61 percent, compared to bortezomib and dexamethasone alone, in patients with multiple myeloma who received at least one prior therapy (Hazard Ratio [HR] = 0.39; 95 percent CI [0.28-0.53], p<0.0001). Overall, the safety of the daratumumab combination therapy was consistent with the known safety profile of daratumumab monotherapy and bortezomib plus dexamethasone, respectively. o These results were presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2016.  The POLLUX (MMY3003) clinical study which showed daratumumab in combination with lenalidomide and dexamethasone reduced the risk of disease progression or death by 63 percent, compared to lenalidomide and dexamethasone alone, in patients with multiple myeloma who received at least one prior therapy (HR=0.37; 95 percent CI [0.27-0.52], p<0.0001). Overall, the safety of the daratumumab combination therapy was consistent with the known safety profile of daratumumab monotherapy and lenalidomide plus dexamethasone, respectively. o These results were presented at the 21st Annual Congress of the European Hematology Association (EHA) in June 2016. The submission also included data from the Phase 1 study of daratumumab in combination with pomalidomide and dexamethasone in patients who received at least two prior lines of therapy.