FDA Approves Treatment for Chronic GVHD

Ibrutinib has been approved by the FDA for a new usage, treatment of adults with chronic graft versus host disease.


A treatment for cancer is finding a new purpose in treating another life-threatening condition. The FDA expanded approval of Ibrutinib for treatment of adults with chronic graft versus host disease (cGVHD) after ≥ 1 treatments have failed. Ibrutinib was previously approved for certain indications in treating chronic lymphocytic leukemia, Waldenström macroglobulinemia, and marginal zone lymphoma.

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An estimated 30% to 70% of patients who receive hematopoietic stem cell transplantation for blood or bone marrow cancer develop cGVHD.

Ibrutinib , a kinase inhibitor, was tested in a single-arm trial of 42 patients with cGVHD. Most had mouth ulcers and skin rashes; > 50% had ≥ 2 organs affected. Their symptoms had persisted despite standard treatment with corticosteroids. In the study, cGVHD symptoms improved in 67%. For nearly half (48%), the improvements lasted for 5 months or longer.

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Common adverse effects include fatigue, bruising, diarrhea, and thrombocytopenia. Serious adverse effects include severe bleeding, infections, and cytopenia.

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