FDA Grants New Indication for Orencia for Acute Graft-Versus-Host Disease Prophylaxis

The FDA approved abatacept (Orencia, Bristol Myers Squibb) with a calcineurin inhibitor (CNI) and methotrexate (MTX) for the prophylaxis of acute graft-versus-host disease (GVHD) in adults and children as young as 24 months undergoing hematopoietic cell transplantation (HCT) from a matched or an allele-mismatched unrelated donor (URD).

 

The approval was based on results from the phase 2 GVHD-1 trial, also known as ABA2 (Abatacept Combined with a Calcineurin Inhibitor and Methotrexate for