Regulatory Affairs

FDA accepts to review AbbVie’s sNDA for ibrutinib in cGVHD

PBR Staff Writer Published 05 April 2017

The US Food and Drug Administration (FDA) has accepted for review AbbVie's supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.

Imbruvica is an oral and once-daily therapy, which suppresses Bruton's tyrosine kinase (BTK) protein, which is a signaling molecule in the B-cell receptor signaling complex that will spread malignant B cells.

GVHD is a condition where the bone marrow tissues of the recipient are attacked by bone marrow donor immune cells after a patient undergoes an allogeneic stem cell or bone marrow transplant.

Imbruvica will become the first therapy for the treatment of cGVHD, if approved by the FDA. It is being developed and commercialized by AbbVie firm Pharmacyclics and Janssen Biotech.

The sNDA was submitted based on data from the single-arm Phase 1b/2 PCYC-1129 trial, which demonstrated the safety and efficacy of ibrutinib in patients with cGVHD who failed first-line corticosteroid therapy and need further systemic therapy.

Pharmacyclics-sponsored has assessed 42 previously treated patients with cGVHD in the US who continued on steroid-based regimens.

 In June 2016, the FDA had granted breakthrough therapy status and orphan drug status for ibrutinib to treat cGVHD after failure of one or more lines of systemic therapy.

Pharmacyclics GVHD program clinical lead and senior medical director Dr Lori Styles said: “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.”

“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.”


Image: AbbVie Corporate Headquarters. Photo: courtesy of AbbVie Inc.