FDA Grants Abatacept Breakthrough Designation for Acute GVHD

December 4, 2019 – The FDA has granted a breakthrough therapy designation for abatacept for the prevention of moderate-to-severe acute graft-versus-host disease (GVHD) in patients who have undergone hematopoietic stem cell transplants (HSCTs) from unrelated donors. The designation is based on results of a phase II investigator-initiated trial, in which the impact of abatacept was evaluated for the prevention of severe acute GVHD when added to a standard GVHD … (leggi tutto)