29 Marzo 2019

FDA Approval Sought for Frontline Daratumumab Regimen in Transplant-Eligible Myeloma

March 26, 2019 – A supplemental biologics license application (sBLA) has been submitted to the FDA for daratumumab in combination with bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The application is based on findings from part 1 of the phase III CASSIOPEIA (MMY3006) trial, in which the stringent complete response (sCR) rate … (leggi tutto)