Weill Cornell Bone Marrow Transplant Program

FDA Approves Ibrutinib for Treatment of Chronic GVHD

On August 2, the United States Food and Drug Administration (FDA) approved the drug ibrutinib for treatment of adults with chronic graft versus host disease (cGVHD).Ibrutinib Pills

GVHD can occur following a stem cell or bone marrow transplant from a related or unrelated donor, also known as an allogeneic transplant. When the immune cells from the graft (donor) are infused into the body of the host (patient), they may recognize the host’s native cells as foreign and try to destroy them. While some cases of GVHD are life threatening, chronic cases tend to generate to more mild symptoms, like dry eyes and mouth, fatigue, and muscle weakness and stiffness.

Ibrutinib becomes the first FDA-approved treatment of cGVHD following clinical trials demonstrating durable safety and effectiveness in patients whose symptoms were resistant to prior corticosteroid treatment administered for immune system suppression.