RARITAN, N.J. — The Food and Drug Administration has given a special designation to a cancer drug under development by Johnson & Johnson and Pharmacyclics, the companies said.
J&J subsidiary Janssen Research & Development and Pharmacyclics announced that the FDA had given breakthrough therapy designations to the experimental drug ibrutinib as a standalone therapy for relapsed or refractory mantle cell lymphoma in patients who have received prior therapy and for Waldenstrom's macroglobulinemia.
