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FDA Breakthrough Therapy Designation: Fourth Drug Receives FDA Approval

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Originally posted on Orphan Druganaut Blog:

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The FDA approves on February 12, the fourth drug to have the coveted Breakthrough Therapy Designation (BTD). The approval is for orphan drug Imbruvica (Ibrutinib) as a single agent for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy. Imbruvica, a once-daily, oral kinase inhibitor, is developed and commercialized by Pharmacyclics and Janssen Biotech. Imbruvica is the :

•   1st FDA BTD drug to receive approval in 2014

•   1st FDA BTD drug to receive approval for a 2nd indication – Mantle Cell Lymphoma (MCL) on 11.13.13

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