August 2, 2017
The U.S. Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD.
Approval was based on Study PCYC-1129-CA (NCT02195869), an open-label, multi-center, single-arm clinical trial enrolling 42 patients with cGVHD after failure of first-line corticosteroid therapy and requiring additional therapy. The majority of patients (88%) had at least two organs involved at baseline. The most common organs involved were mouth (86%), skin (81%), and gastrointestinal tract (33%).