Pharmacyclics Inc. (PCYC) announced the U.S. FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma patients with deletion of the short arm of chromosome 17. The FDA decision was based on data from pre-clinical and clinical studies where ibrutinib as a monotherapy was used to treat patients with the disease.
In February 2013, FDA granted Breakthrough Therapy Designations for ibrutinib as a monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma and as a monotherapy for the treatment of patients with Waldenstrom's macroglobulinemia, both of which are also B-cell malignancies.
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