FDA Approves Imbruvica to Treat Chronic Graft Versus Host Disease
WEDNESDAY, Aug. 2, 2017 -- The U.S. Food and Drug Administration on Wednesday expanded approval for the cancer drug Imbruvica (ibrutinib) to include adults with chronic graft versus host disease (cGVHD).
Use of Imbruvica to treat cGVHD was studied in a clinical trial of 42 patients whose symptoms lingered despite standard corticosteroid treatment. About two-thirds of trial participants had improved symptoms, the FDA said.
Common side effects of the drug included fatigue, bruises, diarrhea, thrombocytopenia, and muscle spasms. More serious adverse reactions could include hemorrhage, infection, atrial fibrillation, and hypertension, the agency said.
"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," Richard Pazdur, M.D., 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 statement. "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."
Imbruvica's latest approval was granted to Pharmacyclics, based in Sunnyvale, Calif.
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Posted: August 2017