Additional Relevant Details Breakthrough Therapy Designation was granted to daratumumab based on data from two Phase 3 studies:

• The MMY3004 (CASTOR) clinical trial evaluating daratumumab in combination with bortezomib and dexamethasone, compared to bortezomib and dexamethasone alone, in patients with multiple myeloma who received at least one prior therapy. Overall, the daratumumab combination therapy demonstrated a reduction in the risk of disease progression or death.
  • These results were presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) inJune 2016. More information can be found at www.ClinicalTrials.gov (NCT02136134).
• The MMY3003 (POLLUX) clinical trial evaluating daratumumab in combination with lenalidomide and dexamethasone, compared to lenalidomide and dexamethasone alone, in patients with multiple myeloma who received at least one prior therapy. Overall, the addition of daratumumab reduced the risk of disease progression or death in these patients.
  • These results were presented at the 21st Annual Congress of the European Hematology Association (EHA) in June 2016. More information can be found at www.ClinicalTrials.gov (NCT02076009).