- 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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