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Obinutuzumab - Roche

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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: 14 Mar 2025

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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 inhibitors; 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
  • Preregistration Lupus nephritis
  • Phase III Diffuse large B cell lymphoma; Glomerulonephritis; 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

  • 05 Mar 2025 The USFDA is expected to make a decision on approval Obinutuzumab for treatment of Lupus nephritis by October 2025
  • 05 Mar 2025 USFDA has accepted the supplemental Biologics License Application (sBLA) for obinutuzumab for the treatment of lupus nephritis
  • 27 Feb 2025 Chugai Pharmaceutical and Roche plans to submit regulatory application for Lupus nephritis in Japan in and after 2027 (Chugai Pharmaceutical pipeline, February 2025)

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