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Obinutuzumab : ウィキペディア英語版 | Obinutuzumab
Obinutuzumab (called afutuzumab until 2009〔(International Nonproprietary Names for Pharmaceutical Substances (INN) ), ''World Health Organization''.〕) 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. It acts as an immunomodulator.〔(Statement On A Nonproprietary Name Adopted By The Usan Council - Afutuzumab ), ''American Medical Association''.〕〔(International Nonproprietary Names for Pharmaceutical Substances (INN) ), ''World Health Organization''.〕 Obinutuzumab targets CD20 and kills B cells.〔 GlycArt's technology platform allowed control of protein glycosylation; the cells in which obinutuzumab is produced were engineered to overexpress two glycosylation enzymes, MGAT3 and Golgi mannosidase 2, which reduce the amount of fucose attached to the antibody, which in turn increases the antibody's ability to activate natural killer cells.〔Ratner M. Genentech's glyco-engineered antibody to succeed Rituxan. Nat Biotechnol. 2014 Jan;32(1):6-7. PMID 24406911〕〔Umaña P et al. Engineered glycoforms of an antineuroblastoma IgG1 with optimized antibody-dependent cellular cytotoxic activity. Nat Biotechnol. 1999 Feb;17(2):176-80. PMID 10052355 〕 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.〔Associated Press, published in the New York Times. November 1, 2013 (F.D.A. Clears New Cancer-Fighting Drug From Roche )〕 ==Breakthrough therapy designation==
(詳細はFood and Drug Administration approved Gazyva for chronic lymphocytic leukemia making it the first drug to receive the coveted breakthrough therapy designation
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