The Food and Drug Administration (FDA) has accepted for review Janssen’s supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
The sNDA submission is based on data from the PCYC-1129 study, a single-arm Phase 1b/2 trial evaluating the efficacy and safety of ibrutinib in patients with cGVHD who have failed first-line corticosteroid therapy and require additional treatment. Findings from this study were presented at the American Society of Hematology Annual Meeting in December 2016 and the Blood and Marrow Transplantation Tandem Meeting in February 2017.
Imbruvica is jointly developed and commercialized by Janssen Biotech and Pharmacyclics. The companies are currently investigating Imbruvica vs. placebo, in addition to corticosteroids, in a Phase 3 trial in patients with new onset moderate or severe cGVHD as a first-line therapy.
Imbruvica is a first-in-class, oral Bruton’s tyrosine kinase (BTK) inhibitor currently approved for the treatment of patients with: 1) Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); 2) CLL/SLL with 17p deletion; 3) Waldenstrom’s macroglobulinemia (WM); 4) Mantle cell lymphoma (MCL) who have received at least one prior therapy; 5) Marginal zone lymphoma (MZL) who require systemic treatment and have received at least one prior anti-CD20-based therapy.
For more information call (800) 526-7736 or visit Janssen.com.