FDA Breakthrough Therapy Designation: Fourth Drug Receives FDA Approval

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