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: 14 Nov 2018

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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 CD20 antigen inhibitors
  • 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; Renal failure

Most Recent Events

  • 01 Nov 2018 Updated efficacy and adverse events data from the phase III CLL14 trial in Chronic lymphocytic leukaemia released by Roche
  • 06 Oct 2018 Roche completes the phase IIIb GREEN trial in Chronic lymphocytic leukaemia in Argentina, Bosnia and Herzegovina, Brazil, Belgium, Canada, Egypt, Estonia, Finland, France, Germany, Greece, Israel, Ireland, Italy, South Korea, Latvia, Lithuania, Macedonia, Mexico, Poland, Portugal, Romania, Russia, Slovakia, Serbia, Slovenia, Spain, Sweden, Switzerland, Thailand and Turkey (IV) (NCT01905943)
  • 25 Sep 2018 Genentech suspends patient enrolment in the phase II PrE0403 trial based upon review of tumour lysis syndrome events in Follicular lymphoma (Combination therapy, First-line therapy, Late-stage disease, Metastatic disease) in USA (IV) (NCT03113422)
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