U.S. FDA Accepts for Review the Application of Ibrutinib (IMBRUVICA®) for Chronic Graft-Versus-Host-

Johnson & Johnson press release -------- Janssen Research & Development, LLC announced today the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA®) for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. GVHD is a potential life-threatening consequence of stem cell or bone marrow transplant, with no approved treatments or established standards of care specifically indicated for the condition in patients who have failed initial steroid therapy. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. To get more in depth information click on the picture below to read the release.