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FDA grants Imbruvica breakthrough designation for chronic GVHD
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The FDA today granted breakthrough therapy designation to ibrutinib as a monotherapy treatment for chronic graft-versus-host disease after failure of one or more lines of systemic therapy.
The FDA also granted ibrutinib (Imbruvica; Pharmacyclics, Janssen) — a first-in-class, oral, once-daily therapy that inhibits Bruton's tyrosine kinase — 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.
“We're hopeful ibrutinib can make a difference and look forward to working with the FDA and our strategic partner, Pharmacyclics, on this development program,” Sen Zhuang, MD, PhD, vice president of clinical development for hematology at Janssen Research & Development, said in a company-issued release.
The FDA previously granted ibrutinib breakthrough therapy designation to treat patients with relapsed or refractory mantle cell lymphoma, Waldenström's macroglobulinemia, and chronic lymphocytic leukemia or small lymphocytic lymphoma with a deletion of the short arm of chromosome 17.