AbbVie recently announced the U.S. Food and Drug Administration's (FDA) approval of IMBRUVICA (ibrutinib) as a potential treatment for chronic graft-versus-host-disease (cGVHD).
The FDA granted ibrutinib its
fourth Breakthrough Therapy Designation (BTD) and also Orphan Drug Designation
(ODD) for this therapy.
"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," Pharmacyclics Head of Oncology Dr. Danelle James said. "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."
Pharmacyclics is a subsidiary of AbbVie.
cGVHD is a difficult to treat condition that may develop after a patient receives a stem cell or bone marrow transplant. The cells from the donor may attack the patient's cells. Currently, patients are prescribed steroids, which can lead to further health complications.
The preliminary data from a Phase Ib/2 study indicated that ibrutinib had a positive effect on cGVHD. This led to the request for a BTD in order to expedite the development and review of the therapy. The ODD status provides additional support to encourage development of treatments for rare diseases and conditions.
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