Janssen’s Darzalex (daratumumab) Combination Regimen Receives EC’s Approval for Transplant Ineligible Patients with Newly Diagnosed Multiple Myeloma

Janssen Reports Results of Ponesimod in P-III OPTIMUM Study for Relapsing Multiple Sclerosis


  • The EC’s approval is based on P-III MAIA study assessing Darzalex + lenalidomide and dexamethasone (DRd) vs Rd in 737 newly diagnosed patients aged 45-90yrs. with multiple myeloma ineligible for high-dose chemotherapy and ASCT
  • The P-III MAIA study results: 44% reduction in the risk of disease progression; CR (48% vs 25%); improvement in VGPR (79% vs 53%); the rate of MRD (24% vs 7%); @median follow up of 28mos. (not reached vs 31.9mos.)
  •  Darzalex is a CD38-directed antibody and is an approved therapy as monothx. or in combination with other drugs in multiple countries including the US for the treatment of multiple myeloma. In Aug’2012, Genmab granted exclusive rights of Darzalex to Janssen

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