Imbruvica for GVHD – pro
On June 29, 2016 the FDA also granted ibrutinib (Imbruvica; Pharmacyclics, Janssen) the orphan drug designation for the same indication. There are currently no therapies specifically approved to treat chronic graft-versus-host disease (GVHD). The decision was based, in part, on preliminary clinical data from a phase 1b/2 study evaluating the safety and efficacy of ibrutinib in patients with steroid-dependent or refractory chronic GVHD. Early efficacy data — presented at the European Society for Blood and Marrow Transplantation Annual Meeting in April and the ASCO Annual Meeting in May — showed ibrutinib improved chronic GVHD based on NIH consensus criteria. This si insufficient tobe called “supported by medical literature”. The authors concluded: “Ibrutinib given for steroid-dependent/refractory cGVHD was well tolerated; AEs were consistent with the known safety profile for ibrutinib. The efficacy data observed at this early time point is preliminary and needs confirmation in a larger number of pts for longer duration. Phase 2 enrollment is ongoing “.
Dignan FL, Amrolia P, Clark A, Cornish J, Jackson G, Mahendra P, Scarisbrick JJ, Taylor PC, Shaw BE, Potter MN, on behalf of the Haemato-oncology Task Force of the British Committee [trunc]. Diagnosis and management of chronic graft-versus-host disease. Br J Haematol 2012 Jul;158(1):46-61. [125 references]
David Bernard Miklos, Mukta Arora, Corey S. Cutler, Ryotaro Nakamura, Manuela Juretic, Yunfeng Li, Lori Appel Styles, Danelle Frances James, Samantha Mary Jaglowski; A multicenter open-label phase 1b/2 study of ibrutinib in steroid dependent or refractory chronic graft versus host disease (cGVHD). J Clin Oncol 33, 2015 (suppl; abstr 7024)