Janssen Research & Development, LLC said FDA has accepted for review a supplemental New Drug Application for ibrutinib (Imbruvica) for the treatment of patients with chronic graft-versus-host-disease after failure of one or more lines of systemic therapy.
Imbruvica is jointly developed and commercialized by Janssen Biotech Inc. and Pharmacyclics LLC, an AbbVie company.
The sNDA is supported by data from a single-arm Phase 1b/2 trial (PCYC-1129) examining the safety and efficacy of ibrutinib in patients with cGVHD who have failed first-line corticosteroid therapy and require additional therapy.
The data was accepted as a late-breaker and presented at the American Society of Hematology annual meeting in December 2016 and the Blood and Marrow Transplantation Tandem Meeting in February 2017.
Based on this data, a phase III study was initiated to evaluate ibrutinib with corticosteroid versus placebo with corticosteroid as a first-line therapy for patients with new onset moderate or severe cGVHD; the trial is currently ongoing.
FDA granted Breakthrough Therapy designation and Orphan Drug designation in June 2016 for ibrutinib as a potential treatment for cGVHD after failure of one or more lines of systemic therapy. Approximately 30-70 percent of post-allogeneic transplant patients develop cGVHD.
