4 December 2019 - Bristol-Myers Squibb today announced that the U.S. FDA has granted breakthrough therapy designation for Orencia (abatacept) for the prevention of moderate to severe acute graft-versus-host disease in haematopoietic stem cell transplants from unrelated donors.
There are no approved therapies for the prevention of acute GvHD, a potentially life-threatening medical complication that can impact patients receiving such transplants for the treatment of certain genetic diseases and haematologic cancers.
The breakthrough therapy designation is based on findings from an investigator-initiated study supported by Bristol-Myers Squibb. This Phase 2 trial assessed the impact of Orencia on the prevention of severe acute GvHD, when added to a standard GvHD prophylactic regimen administered to patients with haematologic malignancies receiving a stem cell transplant from an unrelated, HLA-matched or mismatched donor. A mismatch in HLA increases the risk of GvHD.