In February 2013, the FDA granted Breakthrough Designation for ibrutinib (Johnson & Johnson) as monotherapy for the treatment of patients with 1 of 2 conditions—refractory or relapsed mantle-cell lymphoma or Waldenström’s macroglobulinemia— both of which are B-cell malignancies. In April 2013, the FDA granted ibrutinib a third Breakthrough Designation for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with chromosome 17p deletion. (April 8, 2013)
