Shots:

• The approval is based on P-III MAIA study assessing Darzalex + lenalidomide + dexamethasone (Rd) vs Rd as monothx. in 737 patients with newly diagnosed multiple myeloma who are ineligible for high-dose chemotherapy and ASCT aged 45-90 yrs.
• The P-III MAIA study results: 44% reduction in risk of disease progression; CR (48% vs 25%); PR (79% vs 53%); ORR (93% vs 81%); patients achieving CR & better MRD negativity status (10^-5) (24% vs 7%); @median-follow up of 28mos. mPFS (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: Newswire Canada | Image: Janssen