FDA accepts sNDA for Imbruvica (ibrutinib) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. - AbbVie + Janssen Biotech

AbbVie announced a supplemental New Drug Application (sNDA) was accepted for review by the FDA for ibrutinib (Imbruvica) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. cGVHD is a severe, potentially life-threatening consequence of stem cell or bone marrow transplant. If approved by the FDA, ibrutinib will be the first therapy specifically approved to treat this condition. Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

The Company’s sNDA is based on data from the single-arm Phase 1b/II 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 Pharmacyclics-sponsored study evaluated 42 previously treated patients with cGVHD in the U.S. who continued on steroid-based regimens. Patients received ibrutinib orally, once daily in combination with ongoing therapies, including corticosteroids and other immunosuppressants, until progression/worsening of cGVHD, recurrence of underlying malignancy or unacceptable toxicity. These data were presented as a late-breaker at both the American Society of Hematology Annual Meeting in December 2016 and the Blood and Marrow Transplantation Tandem Meeting in February 2017.