FDA will look into Janssen’s sNDA for ibrutinib

 Janssen Research & Development, said Monday that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for ibrutinib (Imbruvica) for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.

GVHD is a potential life-threatening consequence of stem cell or bone marrow transplant, with no approved treatments or established standards of care specifically indicated for the condition in patients who have failed initial steroid therapy. Imbruvica is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.

“Patients with chronic graft-versus-host-disease face an unpredictable, debilitating and sometimes life-threatening disease journey, which is further complicated by lack of FDA-approved medicines. We hope this filing acceptance and the robust body of evidence supporting ibrutinib in this condition will translate into a future indication in cGVHD and a new, much-needed treatment option,” said Sen Zhuang, from Clinical Development, Hematology for Janssen Research & Development.

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 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, the company said.

GVHD is a medical complication of allogeneic stem cell or bone marrow transplant and can be a serious and debilitating condition. The condition occurs when donor immune cells attack the patients’ tissues and it can affect almost any organ in the body. The incidence of cGVHD has continued to increase over time. In fact, approximately 30-70 percent of post-allogeneic transplant patients develop cGVHD.