Drug Profile


Alternative Names: Afutuzumab; GA 101; Gazyva; Gazyvaro; R 7159; RG 7159; RG 7195; RO 5072759

Latest Information Update: 02 Jan 2017

Price : $50

At a glance

  • Originator GLYCART Biotechnology
  • Developer Biogen Idec; Chugai Pharmaceutical; Dana-Farber Cancer Institute; Genentech; M. D. Anderson Cancer Center; 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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 02 Jan 2017 CTP push 249002 (NCT02292225) - KDM updated; TRial termination HE Added
  • 05 Dec 2016 Efficacy data from phase III GALLIUM trial in Non-Hodgkin's lymphoma presented at the 58th American Society of Hematology Annual Meeting (ASH-2016)
  • 01 Dec 2016 Phase-II clinical trials in Follicular lymphoma (First-line therapy, Late-stage disease, Combination therapy) in USA (IV) (NCT02871219)
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