ORENCIA® (Abatacept)

RR FDA Approvals
General Medical Oncology & Hematology

The FDA on December 15, 2021, approved ORENCIA® (Abatacept) for the prophylaxis of acute Graft Versus Host Disease (aGVHD), in combination with a Calcineurin Inhibitor (CNI) and Methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. This is the first drug approved to prevent aGVHD. The application included use of Real World Data (RWD) in the determination of clinical effectiveness. RWD is clinical data routinely collected from a variety of sources, including registry data, to generate Real World Evidence (RWE). ORENCIA® (Abatacept) is a product of Bristol-Myers Squibb Company.