Obinutuzumab

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Obinutuzumab?
Monoclonal antibody
Type Whole antibody
Source Humanized (from mouse)
Target CD20
Clinical data
Trade names Gazyva, Gazyvaro
Intravenous infusion
Pharmacokinetic data
Half-life 28.4 days
Identifiers
949142-50-1 N
L01XC15
UNII O43472U9X8 YesY
KEGG D09321 YesY
Chemical data
Formula C6512H10060N1712O2020S44
146.1 kDa
 N (what is this?)  (verify)

Obinutuzumab (called afutuzumab until 2009[1]) is a humanized monoclonal antibody, originated by Glycart Biotechnology AG and developed by Biogen Idec, Chugai Pharmaceutical Co., and Hoffmann-La Roche Inc. for the treatment of lymphoma.[2] It acts as an immunomodulator.[3][4]

Obinutuzumab targets CD20 and kills B cells.[2]

Obinutuzumab was approved under the trade name Gazyva by the US FDA in 2013, and as Gazyvaro by the EMA in Europe, for the treatment of chronic lymphocytic leukemia in combination with chemotherapy in treatment-naive patients. Patients treated with Gazyva had median survival of 23 months before death or disease progression, compared with 11.1 months for patients on chemotherapy alone.[5]

UK availability[edit]

In October 2014, NICE announced that NHS England would not fund use of the drug, due to data uncertainties in Roche's application.[6]

References[edit]

  1. ^ International Nonproprietary Names for Pharmaceutical Substances (INN), World Health Organization.
  2. ^ a b Robak, T (2009). "GA-101, a third-generation, humanized and glyco-engineered anti-CD20 mAb for the treatment of B-cell lymphoid malignancies". Current opinion in investigational drugs (London, England : 2000) 10 (6): 588–96. PMID 19513948. 
  3. ^ Statement On A Nonproprietary Name Adopted By The Usan Council - Afutuzumab, American Medical Association.
  4. ^ International Nonproprietary Names for Pharmaceutical Substances (INN), World Health Organization.
  5. ^ Associated Press, published in the New York Times. November 1, 2013 F.D.A. Clears New Cancer-Fighting Drug From Roche
  6. ^ "NICE denies Roche cancer drug due to ‘data uncertainties’". PM Live. Retrieved 3 October 2014.