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AUGUST 7, 2017

FDA Approves Imbruvica to Treat Adults With Chronic GVHD

By SPC News Staff

The FDA granted a new indication for ibrutinib (Imbruvica, Pharmacyclics/Janssen) for the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure with one or more lines of systemic therapy.

With this approval, ibrutinib becomes the first and only therapy specifically approved for adults with cGVHD, a serious and debilitating potential consequence of a stem cell or bone marrow transplant. Ibrutinib is a first-in-class Bruton’s tyrosine