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iNNOVATE Study: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenstrom's Macroglobulinemia

Trial Profile

iNNOVATE Study: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenstrom's Macroglobulinemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Dec 2020

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At a glance

  • Drugs Ibrutinib (Primary) ; Rituximab (Primary)
  • Indications Waldenstrom's macroglobulinaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms iNNOVATE
  • Sponsors Pharmacyclics
  • Most Recent Events

    • 23 Dec 2020 According to an AbbVie media release, results from the final analysis of the study were recently featured as an oral presentation at the 2020 American Society of Hematology (ASH) Annual Meeting (Abstract 336).
    • 23 Dec 2020 According to an AbbVie media release, the company announced that the U.S. Food and Drug Administration (FDA) approved the update of the IMBRUVICA (ibrutinib) Prescribing Information to include efficacy and safety data for the combination of IMBRUVICA with rituximab for the treatment of Waldenstroms macroglobulinemia (WM), based on the final analysis of the Phase 3 iNNOVATE study.
    • 08 Dec 2020 Results from the final analysis of the iNNOVATE open-label substudy presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
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