US FDA approves AbbVie's imbruvica for treatment of adults with cGVHD


The US Food and Drug Administration (FDA) has expanded the approval of imbruvica (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after the failure of one or more treatments.

The therapy is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK).

It is jointly developed and commercialised by AbbVie company Pharmacyclics and Janssen Biotech.

cGVHD is a serious and potentially life-threatening condition that might occur in patients who receive stem cell transplant from blood or bone marrow, known as hematopoietic stem cell transplantation (HSCT).

The tissues of bone marrow recipients are attacked by bone marrow donor immune cells after they undergo an allogeneic stem cell or bone marrow transplant.

Imbruvica is currently the first and only therapy that has been approved to treat adults with cGVHD.

"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."

FDA Oncology Centre of Excellence director Dr Richard Pazdur 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.

“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 current FDA approval is based on results from an open-label, multicentre, single-arm Phase IIb / II trial (PCYC-1129), which studied the safety and efficacy of ibrutinib in 42 cGVHD patients who failed to be treated with the first-line corticosteroid therapy and required additional treatment.

Imbruvica was previously approved for certain indications in treating chronic lymphocytic leukaemia, Waldenström’s macroglobulinemia and marginal zone lymphoma. It is also under accelerated approval status for mantle cell lymphoma.