Obinutuzumab - Roche

Drug Profile

Obinutuzumab - Roche

Alternative Names: 949142-50-1; Afutuzumab; GA-101; Gazyva; Gazyvaro; R-7159; RG 7195; RG-7159; RO-5072759

Latest Information Update: 21 May 2018

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At a glance

  • Originator GLYCART Biotechnology
  • Developer Biogen Idec; Chugai Pharmaceutical; Dana-Farber Cancer Institute; Genentech; Lymphoma Academic Research Organisation; Nippon Shinyaku; OHSU Knight Cancer Institute; Pharmacyclics; Roche; Thomas Jefferson University; University of Heidelberg; University of Leeds
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action CD20 antigen inhibitors; Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Follicular lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia; Follicular lymphoma; Non-Hodgkin's lymphoma
  • Phase III Diffuse large B cell lymphoma
  • Phase II CNS cancer; Graft-versus-host disease; Lupus nephritis; Mantle-cell lymphoma
  • Discontinued Primary biliary cirrhosis; Renal failure

Most Recent Events

  • 24 Apr 2018 Phase-II clinical trials in Follicular lymphoma (Early-stage disease) in Germany (IV) (NCT03341520)
  • 07 Mar 2018 Lymphoma Academic Research Organisation and Roche terminate the phase III GAINED trial in Diffuse large B cell lymphoma (First-line therapy, Combination therapy) in Belgium and France due to inferiority of obinutuzumab compared with rituximab (NCT01659099)
  • 01 Mar 2018 Roche completes a phase II trial in Chronic lymphocytic leukaemia (First-line therapy, Combination therapy) in France (IV) (NCT02666898)
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