AbbVie's Imbruvica sNDA accepted for review by FDA

AbbVie's supplemental new drug application for ibrutinib, a product for treating chronic graft vs. host disease (cGVHD) after failure of one or more lines of systemic therapy, has received FDA approval.
If the FDA approves the drug, the product will be the first specific therapy for cGVHD – a severe, potentially life-threatening consequence of stem cell or bone marrow transplant.
AbbVie’s product, marketed as Imbruvica, is an oral, once-daily therapy; it inhibits a protein called Bruton's tyrosine kinase that is a key signaling molecule in the B-cell receptor.
“Patients with chronic-graft-versus-host-disease are traditionally prescribed corticosteroids, which often do not produce an adequate response and may cause serious health complications for some patients,” Dr. Lori Styles, senior medical director at Pharmacyclics, said. “This regulatory filing is meaningful as it signifies the first potential indication for ibrutinib outside of hematological malignancies in a disease that severely impacts the patient’s quality of life. We are pleased that these patients now have the potential for an effective treatment option.”