Obinutuzumab

Drug Profile

Obinutuzumab

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

Latest Information Update: 28 Sep 2017

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At a glance

  • Originator GLYCART Biotechnology
  • Developer Biogen Idec; Chugai Pharmaceutical; Dana-Farber Cancer Institute; Genentech; Nippon Shinyaku; OHSU Knight Cancer Institute; Roche
  • 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; Non-Hodgkin's lymphoma
  • Registered Follicular 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

  • 22 Sep 2017 Registered for Follicular lymphoma (Combination therapy, First-line therapy) in Liechtenstein, Norway, Iceland, European Union (IV)
  • 30 Aug 2017 FDA assigns PDUFA action date of 23/12/2017 for obinutuzumab for Non-Hodgkin's lymphoma
  • 28 Aug 2017 Preregistration for Follicular lymphoma (Combination therapy, First-line therapy) in USA (IV)
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