The European Medicines Agency review of daratumumab (Darzalex) for the treatment of adult patients newly diagnosed with multiple myeloma.

The European Medicines Agency review of daratumumab (Darzalex) for the treatment of adult patients newly diagnosed with multiple myeloma. Oncologist. 2020 Oct 07;: Authors: Michaleas S, Penninga E, Hovgaard D, Dalseg AM, Rosso A, Sarac SB, Jimenez JC, Fernández LL, Fernández CP, Mangas-SanJuan V, Garcia I, Payares-Herrera C, Sancho-López A, Enzmann H, Silva MSSCL, Duarte S, Pignatti F Abstract The use of daratumumab in combination with established regimens for the treatment of newly diagnosed Multiple Myeloma (MM) has recently been authorised by the European Medicines Agency based on results from 3 separate phase 3 randomized, active controlled open label studies which have confirmed enhanced efficacy and tolerability in both transplant ineligible (MMY3008 and MMY 3007) and eligible patients (MMY3006), without compromising transplant ability. Trial MMY3008 showed an improvement in progression-free survival (PFS) when daratumumab was added to lenalidomide and dexamethasone compared with lenalidomide and dexamethasone; the median PFS had not been reached in the daratumumab arm and was 31.9 months in the control arm (hazard ratio [HR]=0.56; 95% CI: 0.43, 0.73; p<0.0001). Trial MMY3007 showed an improvement in PFS when daratumumab was added to bortezomib, melphalan and prednisone compared with bortezomib, melphalan and prednisone; PFS had not been reached in the daratumumab arm and was 18.1 months in the control arm (HR=0.5; 95% CI...
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Oncologist Source Type: research