FDA Grants Priority Review to GvHD Preventative Abatacept

According to a recent article at Targeted Oncology, the FDA has approved abatacept (Orencia) under priority review for preventing moderate to severe acute graft versus host disease (GvHD). The patients must be receiving unrelated donor hematopoietic stem cell transplantation and be six years of age or older.


Graft-versus-host disease (GvHD) is a complication where transplanted cells attack the recipient’s body. It can occur after certain stem cell or bone marrow transplants.

There are two types of GvHD: acute and chronic. Acute GvHD occurs usually within the first six months after a transplant, whereas chronic GvHD occurs usually more than three months after a transplant and can last a lifetime.

Common symptoms of acute GvHD include:

  • Abdominal pain or cramps, nausea, vomiting, diarrhea
  • Jaundice or other liver issues
  • Skin rash, itching, or redness

Common symptoms of chronic GvHD include:

  • Dry eyes or dry mouth
  • Vision changes
  • Fatigue, muscle weakness
  • Joint pain or stiffness
  • Skin rash
  • Shortness of breath
  • Weight loss


In the phase 2 ABA2 trial, abatacept was evaluated on whether adding a T-cell co-stimulation blockade would significantly reduce GvHD after a hematopoietic stem cell transplantation (HSCT). It was concluded that the combination was safe and effective in reducing GvHD and improving GVHD-related transplant outcomes.

In a press release, the head of Immunology and Fibrosis Development at Bristol Myers Squibb, Mary Beth Harler, MD, said:

“For patients who receive unrelated donor stem cell transplants, in particular for racial and ethnic minority patient populations, there is a heightened risk of developing aGvHD, a potentially life-threatening medical complication for which there are no approved preventive therapies. We look forward to working with the FDA to bring Orencia to this new patient population and employ pathbreaking science in an effort to address unmet needs of underserved patients.”

For more information on abatacept (Orencia) visit Orencia.com.

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