AbbVie announced that the Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy designation for Imbruvica (ibrutinib) and an Orphan Drug designation for the potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. 

The Breakthrough Therapy designation is supported by promising data from a Phase 1b/2 clinical study evaluating the safety and efficacy of ibrutinib in patients with steroid-dependent or refractory cGVHD. Preliminary trial results were previously presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (ESBM) in April 2016 and the 51st American Society of Clinical Oncology (ASCO) Annual Meeting in May 2015. 

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The FDA previously granted Breakthrough Therapy and Orphan Drug designations to Imbruvica for the treatment of relapsed or refractory mantle cell lymphoma (MCL), treatment of Waldenström’s macroglobulinemia (WM), and treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients with a deletion of the short arm of chromosome 17 (del 17p).

Imbruvica is a first-in-class, oral Bruton’s tyrosine kinase (BTK) inhibitor currently approved for the treatment of patients with CLL who have received at least one prior therapy, CLL patients with 17p deletion, patients with WM, and patients with MCL who have received at least one prior therapy.

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