Shots:

• 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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Ref: Businesswire | Image:  Janssen