AbbVie Submits IMBRUVICA® (ibrutinib) Phase III Combination Data to U.S. FDA

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Go back to AbbVie Submits IMBRUVICA® (ibrutinib) Phase III Combination Data to U.S. FDA

AbbVie (ABBV) Submits Phase 3 IMBRUVICA Combo Data to FDA

November 13, 2015 8:07 AM EST

AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for labeling considerations based on safety and efficacy results from the Phase III HELIOS (CLL3001) trial investigating the use of IMBRUVICA® (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in relapsed or refractory patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company, and Janssen Biotech, Inc.

"The HELIOS study will... More