'FDA granted a fourth Breakthrough Therapy Designation (BTD) for ibrutinib (IMBRUVICA®) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. The FDA also granted the therapy Orphan Drug Designation for the condition. cGVHD is a severe and potentially life-threatening condition in which transplanted cells from the donor attack the patient's body. Patients may develop this common complication after undergoing allogeneic stem cell or bone marrow transplantation in which they receive cells from a donor. There are currently no therapies specifically approved for this condition. Most patients with cGVHD are prescribed glucocorticoids, a systemic steroid treatment that is able to act upon cells throughout the entire body; however, research shows that long-term use of steroids can lead to serious health complications.'
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Neil