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Obinutuzumab - Roche

Drug Profile

Obinutuzumab - Roche

Alternative Names: Afutuzumab; GA-101; GAZYVA; Gazyva; Gazyvaro; huMAB(CD20) - Roche; R-7159; RG 7195; RG-7159; RG7159-7; RO-5072759

Latest Information Update: 15 Feb 2023

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At a glance

  • Originator GLYCART Biotechnology
  • Developer Biogen Idec; Chugai Pharmaceutical; Dana-Farber Cancer Institute; Genentech; Lymphoma Academic Research Organisation; Mario Negri Institute for Pharmacological Research; Mayo Clinic; Nippon Shinyaku; OHSU Knight Cancer Institute; Pharmacyclics; Polish Myeloma Consortium; Roche; Thomas Jefferson University; University of Heidelberg; University of Leeds
  • Class Anti-inflammatories; Antineoplastics; Immunotherapies; Monoclonal antibodies; Urologics
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cell death stimulants
  • 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; Glomerulonephritis; Lupus nephritis; Nephrotic syndrome; Systemic lupus erythematosus
  • Phase II CNS cancer; Focal segmental glomerulosclerosis; Graft-versus-host disease; Mantle-cell lymphoma; Waldenstrom's macroglobulinaemia
  • Discontinued Primary biliary cirrhosis

Most Recent Events

  • 06 Feb 2023 Phase-III clinical trials in Nephrotic syndrome (In adolescents, In children, In adults, Combination therapy, Treatment-experienced) in Belgium, Poland, Japan (IV) (NCT05627557) (EudraCT2022-000369-42)
  • 23 Jan 2023 M.D. Anderson Cancer Center completes a phase I/II trial for Lymphoma (combination therapy, second-line therapy or greater) in USA (NCT01995669)
  • 16 Jan 2023 Updated efficacy and safety results from a phase Ib/II trial for Follicular lymphoma and Diffuse large B-cell lymphoma presented at the 64th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2022)
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