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News|Articles|June 30, 2016
Ibrutinib Receives Orphan Drug and Breakthrough Therapy Designation for cGVHD
Author(s)Pharmaceutical Technology Editors
The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.
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On June 29, 2016 FDA granted Imbruvica (ibrutinib) Breakthrough Therapy designation and Orphan Drug designation as a monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure or one more lines of systematic therapy. This is the fourth Breakthrough Therapy designation for the drug,
Imbruvica works by blocking Bruton’s tyrosine kinase (BTK). The BTK protein transmits signals that tell B cells to mature and multiply. Imbruvica targets and blocks BTK, inhibiting cancerous B cells to survive and spread. Imbruvica is currently being studied alone in combination with other treatments in several blood and solid tumor cancers and other serious illnesses.
Imbruvica is co-developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.
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