FDA Accepts Ibrutinib Application for GVHD

April 4, 2017 – The FDA has accepted a supplemental new drug application (sNDA) for ibrutinib as a treatment for patients with chronic graft-versus-host-disease (cGVHD) after failure of 1 or more lines of systemic therapy, according to Janssen and AbbVie, the codevelopers of the BTK inhibitor. The sNDA is based on data from the single-arm phase Ib/II PCYC-1129 trial, which were first presented during the 2016 ASH Annual Meeting. In the study, ibrutinib … (leggi tutto)