BRIEF—'Breakthrough' status for Orencia in GvHD

The US Food and Drug Administration 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.

Orencia generated full-year sales of up 9% at $2.71 billion for Bristol-Myers Squibb last year.

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, according to B-MS.

The Breakthrough designation is based on findings from an investigator-initiated study supported by B-MS.

This Phase II 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 hematologic malignancies receiving a stem cell transplant from an unrelated, HLA-matched or mismatched donor.

A mismatch in HLA increases the risk of GvHD.