FDA approves Imbruvica expansion to treat chronic graft versus host disease

SILVER SPRING, Md. — Janssen Biotech and Pharmacyclics’ Imbruvica (ibrutinib) has a new indication. The Food and Drug Administration on Wednesday approved the drug to treat adults with chronic graft versus host disease after one or more treatments have failed.

This approval makes Imbruvica the first FDA-approved treatment for the illness, which afflicts patients who have received hematopoietic stem cell transplantation to treat blood or bone marrow cancers. The illness occurs when cells from the stem cell transplant attack healthy cells in a patient’s tissues.

"Patients with [chronic graft versus host disease] 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," said 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. "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 has previously been 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. The drug received priority review and breakthrough therapy designations, as well as orphan drug designation for this indication.