Posted by Michael Wonder on 29 Jun 2016
Ibrutinib (Imbruvica) granted breakthrough therapy designation by U.S. FDA for the development of a treatment for chronic graft-versus-host disease
29 June 2016 - In current clinical practice, there are no FDA-approved treatments for this life-threatening condition.
The U.S. FDA has granted a fourth Breakthrough Therapy Designation (BTD) for ibrutinib (Imbruvica): as monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy, Janssen Research & Development, LLC announced today.
The FDA also granted the therapy orphan drug designation (ODD) for cGVHD. 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. 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.
