EU Approval Sought for Frontline Daratumumab/Rd in Transplant-Ineligible Myeloma

March 22, 2019 – A Type II variation application has been submitted to the European Medicines Agency for the combination of daratumumab with lenalidomide and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). The application is based on results from the phase III MAIA (MMY3008) trial, which showed that the daratumumab regimen led to a 44% reduction in … (leggi tutto)