ARTICLE | Clinical News
FDA approves Imbruvica to treat chronic GvHD
August 4, 2017 7:50 PM UTC
FDA approved Imbruvica ibrutinib (PCI-32765) from AbbVie Inc. (NYSE:ABBV) and Johnson & Johnson (NYSE:JNJ) to treat adults with chronic graft-versus-host-disease (GvHD) after failure of ≥1 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, Dec. 9, 2016)...
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