Medinews
29 Marzo 2019

EU Application Filed for Daratumumab in Newly Diagnosed, Transplant-Eligible Myeloma

March 27, 2019 – A Type II variation application has been submitted to the European Medicines Agency for the 4-drug regimen of daratumumab, bortezomib, thalidomide, and dexamethasone as a treatment for patients with newly diagnosed multiple myeloma who are eligible to undergo autologous stem cell transplant (ASCT). The submission is based on part 1 from the phase III CASSIOPEIA (MMY3006) trial, which demonstrated a 28.9% stringent complete … (leggi tutto)

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