Shots:

• The approval is based on P-III MAIA study results assessing Darzalex + Lenalidomide + Dexamethasone (Rd) vs Rd as monothx. in 737 newly diagnosed patients with multiple myeloma ineligible for high-dose CT and ASCT aged 45-90yrs.
• The P-III MAIA (MMY3008) study results: 44% reduction of disease progression or death; CR (48% vs 25%); VGPR (79% vs 53%); OR (93% vs 81%); MRD negativity (24% vs 7%). The approval of the combination is through the U.S. FDA’s Real-Time Oncology Review (RTOR) pilot program
• 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: Janssen | Image: Janssen