- 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
Click here to read full press release/ article | Ref: Newswire Canada | Image: Ois.net