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FDA approves chronic graft versus host disease treatment

Chronic graft versus host disease is a life-threatening condition that occurs in patients after they receive a stem cell transplant from blood to bone marrow called hematopoietic stem cell transplantation.

By Amy Wallace
FDA approves chronic graft versus host disease treatment
Peripheral blood smear showing Chronic lymphocytic leukemia cells. The U.S. Food and Drug Administration has approved a new treatment for chronic graft versus host disease. Photo by Mary Ann Thompson/Wikimedia Commons

Aug. 3 (UPI) -- The U.S. Food and Drug Administration announced Wednesday it has approved a new treatment for adult patients with chronic graft versus host disease, or cGVHD.

cGVHD is a life-threatening condition that occurs in patients after they receive a stem cell transplant from blood to bone marrow called hematopoietic stem cell transplantation, or HSCT, to treat certain blood or bone marrow cancers such as leukemia.

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cGVHD occurs in 30 to 70 percent of all patients who receive HSCT and can affect the skin, eyes, mouth, gut, liver and lungs.

The FDA approved Imbruvica, or ibrutinib, for the treatment of adult patients with cGVHD who have tried other treatments that were unsuccessful.

"Patients with cGVHD who do not respond to other forms of therapy -- typically corticosteroids to suppress their immune system -- now have a treatment option specifically indicated to treat their condition," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a press release.

"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."

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Imbruvica is a kinase inhibitor that was previously approved for treatment of chronic lymphocytic leukemia, Waldenström's macroglobulinemia and marginal zone lymphoma.

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