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On 22 August 2019, Genmab A/S (Nasdaq: GMAB) announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan had approved the use of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT).1
The approval was based on data from the phase III ALCYONE study (NCT02195479) 2 which showed a 50% reduction in the risk of disease progression or death with daratumumab combined with VMP in newly diagnosed patients with MM who were ineligible for ASCT. The MM Hub previously reported the results of this trial when it was presented as a late-breaking abstract at the 2017 American Society of Hematology (ASH) Annual Meeting.
Daratumumab is the first human CD38 monoclonal antibody (mAb) to reach the market in the United States, Europe, and Japan for the treatment of MM.3
Daratumumab is an IgG1κ mAb that has a high affinity for CD38, which is overexpressed on MM cells. Daratumumab induces MM cell death through various mechanisms including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, antibody-dependent cellular phagocytosis and apoptosis.4
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