Genmab, the Danish biotechnology company, and its collaborative partner, Janssen Biotech Inc., have announced that the US Food and Drug Administration (FDA) has approved the use of daratumumab as a treatment for relapsed and/or refractory myeloma patients who have received at least three previous lines of treatment including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD). Daratumumab is the first monoclonal antibody to be approved for myeloma, based on the pivotal Phase II SIRIUS (MMY2002) trial which reported single agent activity, generating an overall response rate of 29.2% and a median duration of response of 7.4 months, in heavily pretreated patients. The current indication has been awarded under accelerated approval based on response rate and continued approval may be contingent on further trial data. Daratumumab will be referred to by its brand name Darzalex®. It is currently being assessed by the European Medicines Agency (EMA) where a decision is expected in mid-2016.


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