U.S. FDA approves Bristol Myers Squibb’s Orencia

Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant

Bristol Myers Squibb announced that Orencia (abatacept) was approved by the U.S. Food and Drug Administration (FDA) for the prevention 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 (URD).2

“Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant, a potentially life-threatening complication that can pose a comparatively higher risk to racial and ethnic minority populations in the U.S. due to difficulty finding appropriately matched donors,” said Tina Deignan, senior vice president, U.S. Immunology, Bristol Myers Squibb. “With this fourth indication for Orencia, Bristol Myers Squibb draws on its legacy and expertise in both immunology and haematology to deliver an important treatment option for patients in a disease with high unmet need.”

Allogeneic HSCT is a treatment for hematologic diseases that involves the infusion of hematopoietic stem cells, which include donor T-cells, a type of white blood cell that recognizes and destroys foreign invaders and damaged or cancerous cells in the recipient’s body. Acute graft versus host disease occurs when the donor T-cells recognize the patient’s healthy cells as foreign and start attacking healthy tissues and organs.

Orencia – a therapy that is also currently approved to treat adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, and moderate to severe polyarticular juvenile idiopathic arthritis in children 2 and older – binds to and modulates protein targets involved in costimulation, thus inhibiting T-cell activation.2 The relationship of these biological response markers to the mechanisms by which Orencia exerts its clinical effects is unknown.

An abstract with the GVHD-2 data was presented at the American Society of Hematology Annual Meeting and Exposition in December 2021.

The FDA’s review was conducted under its Project Orbis initiative, which enabled concurrent and/or shared FDA review with the health authorities in Canada, Switzerland and as a pilot in Israel. Orencia is not approved for this indication in these countries.