Additional Efficacy and Safety Data for IMBRUVICA® (Ibrutinib) Submitted to FDA Data submission includes findings from the Phase 3 HELIOS (CLL3001) trial evaluating ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

HORSHAM, Pa., Nov. 13, 2015 /PRNewswire/ -- Janssen Biotech, Inc. announced a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) has been submitted to the U.S. Food and Drug Administration (FDA), based on results from the Phase 3 HELIOS (CLL3001) trial evaluating IMBRUVICA® (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). IMBRUVICA is jointly developed and commercialized by Janssen and Pharmacyclics LLC, an AbbVie company. Pharmacyclics is the investigational new drug (IND) holder for IMBRUVICA in the U.S. and submitted the...