The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Darzalex (daratumumab; Janssen Biotech) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of multiple myeloma in patients who have received at least one prior therapy.

The Breakthrough Therapy designation, second for Darzalex, was based on data from two Phase 3 trials, MMY3004 (CASTOR) and MMY3003 (POLLUX). Both studies showed that combination therapy with daratumumab reduced the risk of disease progression or death in patients with multiple myeloma who received at least one prior therapy. Study data from the CASTOR and POLLUX trials were presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) and at the 21st Annual Congress of the European Hematology Association (EHA) in June 2016, respectively. 

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Darzalex is the first CD38-directed monoclonal antibody (mAb) approved in the world. It was approved by the FDA in November 2015 for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

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