Ibrutinib Becomes First FDA-Approved Drug for Chronic Graft-Versus-Host Disease

August 11, 2017, by NCI Staff

erythema skin rash caused by graft-versus host disease

Skin changes caused by chronic graft-versus-host disease.

Credit: National Cancer Institute

A drug currently used to treat several forms of blood cancer, ibrutinib (Imbruvica®), has been approved by the Food and Drug Administration (FDA) for the treatment of chronic graft-versus-host disease (cGVHD). The agency’s decision, announced on August 2, makes ibrutinib the first approved therapy for this potentially fatal and common side effect of cancer-related stem cell transplants.

The approval covers the use of ibrutinib in patients with cGVHD that is not responding to other standard treatments, namely corticosteroids.

Ibrutinib is already approved by FDA for the treatment of several types of lymphoma and chronic lymphocytic leukemia. It works primarily by blocking the activity of a protein known as BTK, which is present in B cells and other types of immune cells.

GVHD occurs when transplanted immune cells attack healthy tissues. Chronic GVHD occurs when the condition arises or persists months after the transplant. GVHD can cause multiple, often debilitating symptoms, including widespread skin rashes, painful mouth ulcers, shortness of breath, and limb and joint pain.

The agency’s approval was based on a nonrandomized clinical trial in which nearly half of patients treated with ibrutinib had significant improvement in their GVHD-related symptoms for at least 5 months.

A January 2017 Cancer Currents post described details of the ibrutinib clinical trial and its potential impact on patient care.


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