FDA gives Imbruvica go-ahead to aid patients with chronic graft versus host disease
The Food and Drug Administration gave Imbruvica the go-ahead to be used to fight chronic graft versus host disease (GVHD) after one or more treatments aimed at fighting disease have not worked.
Chronic GVHD is a potentially life-threatening condition than can occur when donated bone marrow or stem cells attack a transplant patient's body.
The approval comes based on the outcomes of a Phase 1b/2 study of Imbruvica (ibrutinib) involving 42 people with chronic GVHD who experienced no success with an initial corticosteroid treatment and required additional treatment, an AbbVie release said.
"The FDA's approval of Imbruvica in chronic graft versus host disease after failure of one or more lines of systemic therapy addresses an area of high unmet medical need for patients and marks the first approved use for the therapy outside of blood cancers," Lori Styles senior medical director and GVHD program clinical lead at Pharmacyclics LLC, an AbbVie company, said in the release.
Pharmacyclics and Janssen Biotech created and sell Imbruvica.
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