AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted a fourth Breakthrough Therapy Designation (BTD) for ibrutinib (IMBRUVICA®) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
cGVHD is a severe and potentially life-threatening condition in which transplanted cells from the donor attack the patient's body. There are currently no therapies specifically approved for this condition.
The request for a BTD for ibrutinib in patients with cGVHD was based on preliminary clinical data from a Phase 1b/2 study evaluating the safety and efficacy of ibrutinib for the treatment of patients with steroid-dependent or refractory cGVHD. Preliminary results from this trial 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.
"This fourth Breakthrough Therapy Designation from the FDA shows the promise of IMBRUVICA and its unique mechanism of action as a potential therapy beyond blood cancers, including chronic graft-versus-host-disease, a severe inflammatory condition with currently no approved therapies specifically for these patients," said Danelle James, M.D., M.S., Head of Oncology at Pharmacyclics. "We are committed to continuing to evaluate the potential benefit ibrutinib may offer in treating blood cancers, solid tumors and other health conditions with unmet medical needs."
In February 2013, the FDA granted BTD to IMBRUVICA for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) and for the treatment of patients with Waldenström's macroglobulinemia (WM). In April 2013, IMBRUVICA was awarded a third BTD for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with a deletion of the short arm of chromosome 17 (del 17p). The Administration also assigned IMBRUVICA ODD for all three indications.
IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.
