FDA approves treatment for chronic graft versus host disease
FDA expanded on August 2 the approval of ibrutinib (Imbruvica—Pharmacyclics) for the treatment of adults with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.
FDA expanded on August 2 the approval of ibrutinib (Imbruvica—Pharmacyclics) for the treatment of adults with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD. Richard Pazdur, MD, director of FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, noted: "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." The drug, a kinase inhibitor, was previously approved for certain indications in treating chronic lymphocytic leukemia, Waldenström's macroglobulinemia and marginal zone lymphoma, as well as under accelerated approval status for mantle cell lymphoma. A single-arm trial of 42 patients with cGVHD whose symptoms persisted despite standard treatment with corticosteroids found that 67% of patients experienced improvements in their cGVHD symptoms. In addition, 48% of patients in the trial saw their symptoms improve for up to 5 months or longer. Common adverse effects of ibrutinib in patients with cGVHD include fatigue, bruising, diarrhea, thrombocytopenia, muscle spasms, stomatitis, nausea, hemorrhage, anemia, and pneumonia. Serious adverse effects of the drug include hemorrhage, infections, cytopenias, atrial fibrillation, hypertension, new cancers, and metabolic abnormalities. Women who are pregnant or breastfeeding should not take ibrutinib because it may cause harm to a developing fetus or a newborn baby.