FDA Grants Frontline Daratumumab Regimen Priority Review in Transplant-Eligible Myeloma

May 31, 2019 – The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) 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 sBLA is based on findings from part 1 of the phase III CASSIOPEIA (MMY3006) trial, in which the stringent complete response … (leggi tutto)