Additional Relevant Details This marks the first time ibrutinib has been granted BTD or ODD for an indication beyond hematologic malignancies. In current clinical practice, there are no approved treatments or established standards of care specifically indicated for patients with active cGVHD who have failed first-line corticosteroid therapy and require additional therapy. GVHD is a life-threatening condition in which the body is attacked by donor immune cells after a patient undergoes an allogeneic stem cell or bone marrow transplant.[1],[2] Currently, most GVHD patients are prescribed glucocorticoids, a type of steroid treatment, but many do not respond. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.


The FDA granted ibrutinib BTD for cGVHD based on data from a Phase 1b/2 study. Overall, ibrutinib showed early clinical activity in the reduction of cGVHD based on the National Institutes of Health (NIH) Consensus Response Criteria. Preliminary results from this trial were previously presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (ESBM) in April 2016 and the 51st American Society of Clinical Oncology (ASCO) Annual Meeting in May 2015.