Ibrutinib: Imbruvica

CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.

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Study Indication or Disease
Study Name
PCYC-1130-CA AbbVie_IU_icons_outlined_v3 Chronic Lymphocytic Leukemia Phase 3 A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton’s Tyrosine Kinase Inhibitor Ibrutinib in Combination with Obinutuzumab versus Chlorambucil in Combination with Obinutuzumab in Subjects with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
PCYC-1127-CA AbbVie_IU_icons_outlined_v3 Waldenstrom’s Macroglobulinemia Phase 3 A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination with Rituximab in Subjects with Waldenstrom’s Macroglobulinemia