Imbruvica approval expanded to include graft versus host disease

(HealthDay)—The U.S. Food and Drug Administration on Wednesday expanded approval for the anti-cancer drug Imbruvica (ibrutinib) to include adults with chronic graft versus host disease (cGVHD).

cGVHD is a deadly condition that affects up to 70 percent of people who receive a to treat cancers of the blood or , the FDA said in a news release. The condition occurs when the transplanted cells attack healthy cells in a patient's tissues.

"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," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.

Use of Imbruvica to treat cGVHD was studied in a clinical trial of 42 people whose symptoms lingered despite standard corticosteroid treatment. About two-thirds of trial participants had improved symptoms, which often included mouth ulcers and skin rashes, the FDA said.

Common side effects of the drug included fatigue, bruises, diarrhea, a drop in and muscle spasms. More serious adverse reactions could include severe bleeding, infection, irregular heartbeat and , the agency said.

Women who are pregnant or breast-feeding shouldn't take Imbruvica, the FDA warned, as the drug could harm a developing fetus or newborn.

Imbruvica's latest approval was granted to Pharmacyclics, based in Sunnyvale, Calif.


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