First chronic GVHD therapy receives FDA support
medwireNews: Ibrutinib has been granted US FDA approval for the treatment of adults with chronic graft versus host disease (GVHD) who have previously received corticosteroid therapy and other agents.
The approval follows results from the open-label PCYC-1129-CA study showing an overall response rate to ibrutinib 420 mg/day of 67%, with responses achieved in skin, mouth, gastrointestinal tract, and liver affected by chronic GVHD.
The small molecule therapy targeting Bruton’s tyrosine kinase has previously been approved for a number of hematologic conditions including chronic lymphocytic leukemia, small lymphocytic lymphoma with or without a 17p deletion, and mantle cell lymphoma.
“This approval highlights how a known treatment for cancer is finding a new use in treating a serious and life-threatening condition that may occur in patients with blood cancer who receive a stem cell transplant,” commented Richard Pazdur from the FDA’s Center for Drug Evaluation and Research to the press.
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