FDA Approves Frontline Daratumumab/Rd in Transplant-Ineligible Myeloma

June 27, 2019 – The FDA has approved 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 approval, which was granted through the agency’s Real-Time Oncology Review pilot program, is based on findings from the phase III MAIA (MMY3008) trial, in which the daratumumab regimen led to a 44% reduction in the … (leggi tutto)