FDA gives breakthrough therapy designations to experimental cancer drug
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.
The breakthrough therapy designation was enacted as part of the 2012 FDA Safety and Innovation Act. The agency uses it to expedite development and review time for a potential new medicine for a serious or life-threatening disease or condition in cases when evidence suggests the drug may demonstrate substantial improvement over existing therapies.