BMS announces FDA breakthrough therapy designation for Orencia to help prevent acute graft-versus-host disease, a potentially life-threatening complication after stem cell transplant.- BMS

Bristol-Myers Squibb Company announced that the FDA has granted Breakthrough Therapy Designation for Orencia (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic 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 hematologic cancers.

Stem cell transplants have been shown to be an effective treatment for aggressive leukemias and other hematological malignancies, often representing the only therapeutic option for cure. However, some of their benefit is offset by the occurrence of severe acute GvHD, which impacts up to 40 percent of patients receiving stem cell transplants from unrelated donors with a mismatch in genes called human leukocyte antigens (HLA). These transplants are associated with a high rate of transplant-related mortality stemming largely from severe acute GvHD. Stem cell transplant infusions include donor T-cells, a type of white blood cell that recognizes and destroys foreign invaders in the recipient�s body including cancer cells. GvHD occurs when the donor T-cells also recognize the patient�s healthy cells as foreign and start attacking healthy tissues and organs. T-cell activation requires a signaling process called co-stimulation. Orencia, a therapy currently approved to treat various arthritic conditions, binds to and inhibits protein targets involved in co-stimulation, thus inhibiting T-cell activation.