FDA Approves Ibrutinib for GVHD

August 2, 2017 – The FDA has approved ibrutinib for the treatment of adult patients with chronic graft versus host disease (cGVHD) following the failure of 1 or more lines of systemic therapy. The BTK inhibitor is now the first FDA-approved therapy for the treatment of cGVHD. The approval is based on data from the single-arm phase Ib/II PCYC-1129 trial, in which ibrutinib induced an overall response rate of 67% (28/42 patients; 95% CI, 51-80) and showed clinically … (leggi tutto)