FDA Accepts AbbVie sNDA for Imbruvica

FDA has accepted for review an AbbVie a supplemental NDA for Imbruvica (ibrutinib) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. The therapy is currently approved to treat patients with certain types of non-Hodgkin’s lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma, including patients with 17p deletion; patients with mantle cell lymphoma who have received at least one prior therapy; patients with Waldenström's macroglobulinemia; and patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.

The submission is based on data from the single-arm Phase 1b/2 PCYC-1129 trial examining the safety and efficacy of ibrutinib in patients with cGVHD who failed first-line corticosteroid therapy and require further systemic therapy. The data were presented as a late-breaker at both the American Society of Hematology annual meeting 12/2016.