FDA approves Imbruvica for GvHD

FDA approved Imbruvica ibrutinib from AbbVie Inc. (NYSE:ABBV) and Johnson & Johnson (NYSE:JNJ) to treat adults with chronic graft-versus-host-disease (GvHD) after failure of one or more lines of systemic therapy. The agency said Imbruvica is the first FDA-approved therapy to treat chronic GvHD.

FDA based the approval on data from the Phase Ib/II PCYC-1129 trial in which Imbruvica led to an overall response rate (ORR) of 67% in 42 evaluable GvHD patients who failed prior systemic therapy (see BioCentury Extra, Dec. 6, 2016)...