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Obinutuzumab - Roche

Drug Profile

Obinutuzumab - Roche

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

Latest Information Update: 22 Jan 2020

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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; Polish Myeloma Consortium; Roche; Thomas Jefferson University; University of Heidelberg; University of Leeds
  • Class Anti-inflammatories; Antineoplastics; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; 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; Waldenstrom's macroglobulinaemia
  • Discontinued Primary biliary cirrhosis

Most Recent Events

  • 09 Jan 2020 Genentech suspends patient enrolment in the phase II PrE0403 trial in Follicular lymphoma (Combination therapy, First-line therapy, Late-stage disease, Metastatic disease) in USA due to safety (IV) (NCT03113422)
  • 08 Jan 2020 Roche plans a phase III trial for Lupus Nephritis in Mexico, Italy and Israel (IV) (NCT04221477)
  • 13 Dec 2019 Efficacy and adverse events data from the phase III GOYA trial in Diffuse large B-cell lymphoma presented at the 61st Annual Meeting and Exposition of the American Society of Hematology (ASH-HEM-2019)
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