Literature DB >> 24338113

Obinutuzumab: first global approval.

Fiona Cameron1, Paul L McCormack.   

Abstract

Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death. Obinutuzumab is a type II anti-CD20 antibody that induces enhanced direct cell death. The monoclonal antibody is in worldwide phase III development with Roche and its subsidiaries, Genentech and Chugai Pharmaceutical, as well as Biogen Idec, for diffuse large B-cell lymphoma and non-Hodgkin's lymphoma generally, and is also in phase III development in countries outside of the US and EU for CLL.

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Year:  2014        PMID： 24338113     DOI： 10.1007/s40265-013-0167-3

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  18 in total

1.  B-cell depletion with anti-CD20 ameliorates autoimmune cholangitis but exacerbates colitis in transforming growth factor-beta receptor II dominant negative mice.

Authors:  Yuki Moritoki; Zhe-Xiong Lian; Keith Lindor; Joseph Tuscano; Koichi Tsuneyama; Weici Zhang; Yoshiyuki Ueno; Robert Dunn; Marilyn Kehry; Ross L Coppel; Ian R Mackay; M Eric Gershwin
Journal:  Hepatology       Date:  2009-12       Impact factor: 17.425

Review 2.  Advances in the management of follicular lymphoma.

Authors:  Till M Seiler; Wolfgang Hiddemann
Journal:  Curr Opin Oncol       Date:  2012-11       Impact factor: 3.645

3.  Epitope characterization and crystal structure of GA101 provide insights into the molecular basis for type I/II distinction of CD20 antibodies.

Authors:  Gerhard Niederfellner; Alfred Lammens; Olaf Mundigl; Guy J Georges; Wolfgang Schaefer; Manfred Schwaiger; Andreas Franke; Kornelius Wiechmann; Stefan Jenewein; Jerry W Slootstra; Peter Timmerman; Annika Brännström; Frida Lindstrom; Ekkehard Mössner; Pablo Umana; Karl-Peter Hopfner; Christian Klein
Journal:  Blood       Date:  2011-03-28       Impact factor: 22.113

4.  Obinutuzumab (GA101) monotherapy in relapsed/refractory diffuse large b-cell lymphoma or mantle-cell lymphoma: results from the phase II GAUGUIN study.

Authors:  Franck Andre Morschhauser; Guillaume Cartron; Catherine Thieblemont; Philippe Solal-Céligny; Corinne Haioun; Reda Bouabdallah; Pierre Feugier; Krimo Bouabdallah; Elina Asikanius; Guiyuan Lei; Michael Wenger; Elisabeth Wassner-Fritsch; Gilles Andre Salles
Journal:  J Clin Oncol       Date:  2013-07-08       Impact factor: 44.544

Review 5.  Current status of targeted therapies for mantle cell lymphoma.

Authors:  Julie E Chang; Brad S Kahl
Journal:  Drugs       Date:  2011-12-03       Impact factor: 9.546

Review 6.  Optimal pharmacotherapeutic management of chronic lymphocytic leukaemia: considerations in the elderly.

Authors:  Valentin Goede; Michael Hallek
Journal:  Drugs Aging       Date:  2011-03-01       Impact factor: 3.923

7.  Antibody-induced nonapoptotic cell death in human lymphoma and leukemia cells is mediated through a novel reactive oxygen species-dependent pathway.

Authors:  Jamie Honeychurch; Waleed Alduaij; Mahsa Azizyan; Eleanor J Cheadle; Helene Pelicano; Andrei Ivanov; Peng Huang; Mark S Cragg; Tim M Illidge
Journal:  Blood       Date:  2012-02-21       Impact factor: 22.113

8.  Phase I study of obinutuzumab (GA101) in Japanese patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

Authors:  Michinori Ogura; Kensei Tobinai; Kiyohiko Hatake; Toshiki Uchida; Tatsuya Suzuki; Yukio Kobayashi; Masakazu Mori; Yasuhito Terui; Masahiro Yokoyama; Tomomitsu Hotta
Journal:  Cancer Sci       Date:  2012-11-12       Impact factor: 6.716

9.  Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models.

Authors:  Sylvia Herter; Frank Herting; Olaf Mundigl; Inja Waldhauer; Tina Weinzierl; Tanja Fauti; Gunter Muth; Doris Ziegler-Landesberger; Erwin Van Puijenbroek; Sabine Lang; Minh Ngoc Duong; Lina Reslan; Christian A Gerdes; Thomas Friess; Ute Baer; Helmut Burtscher; Michael Weidner; Charles Dumontet; Pablo Umana; Gerhard Niederfellner; Marina Bacac; Christian Klein
Journal:  Mol Cancer Ther       Date:  2013-07-19       Impact factor: 6.261

10.  Obinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000).

Authors:  John Radford; Andrew Davies; Guillaume Cartron; Franck Morschhauser; Gilles Salles; Robert Marcus; Michael Wenger; Guiyuan Lei; Elisabeth Wassner-Fritsch; Umberto Vitolo
Journal:  Blood       Date:  2013-07-10       Impact factor: 22.113
View more
  10 in total

Review 1.  Idelalisib: first global approval.

Authors:  Anthony Markham
Journal:  Drugs       Date:  2014-09       Impact factor: 9.546

Review 2.  IgE immunotherapy against cancer.

Authors:  Lai Sum Leoh; Tracy R Daniels-Wells; Manuel L Penichet
Journal:  Curr Top Microbiol Immunol       Date:  2015       Impact factor: 4.291

Review 3.  Optimizing antiviral agents for hepatitis B management in malignant lymphomas.

Authors:  Oluwatobi O Ozoya; Julio Chavez; Lubomir Sokol; Samir Dalia
Journal:  Ann Transl Med       Date:  2017-02

Review 4.  Hepatitis B Reactivation with Novel Agents in Non-Hodgkin's Lymphoma and Prevention Strategies.

Authors:  Oluwatobi O Ozoya; Lubomir Sokol; Samir Dalia
Journal:  J Clin Transl Hepatol       Date:  2016-06-15

5.  Assessing the Heterogeneity of the Fc-Glycan of a Therapeutic Antibody Using an engineered FcγReceptor IIIa-Immobilized Column.

Authors:  Masato Kiyoshi; Jose M M Caaveiro; Minoru Tada; Hiroko Tamura; Toru Tanaka; Yosuke Terao; Koldo Morante; Akira Harazono; Noritaka Hashii; Hiroko Shibata; Daisuke Kuroda; Satoru Nagatoishi; Seigo Oe; Teruhiko Ide; Kouhei Tsumoto; Akiko Ishii-Watabe
Journal:  Sci Rep       Date:  2018-03-02       Impact factor: 4.379

Review 6.  FDA-Approved Drugs for Hematological Malignancies-The Last Decade Review.

Authors:  Aleksandra Sochacka-Ćwikła; Marcin Mączyński; Andrzej Regiec
Journal:  Cancers (Basel)       Date:  2021-12-24       Impact factor: 6.639

Review 7.  Immunoglobulin Glycosylation - An Unexploited Potential for Immunomodulatory Strategies in Farm Animals.

Authors:  Kristina Zlatina; Sebastian P Galuska
Journal:  Front Immunol       Date:  2021-10-18       Impact factor: 7.561

8.  Biophysical Evaluation of Rhesus Macaque Fc Gamma Receptors Reveals Similar IgG Fc Glycoform Preferences to Human Receptors.

Authors:  Andrew R Crowley; Nana Yaw Osei-Owusu; Gillian Dekkers; Wenda Gao; Manfred Wuhrer; Diogo M Magnani; Keith A Reimann; Seth H Pincus; Gestur Vidarsson; Margaret E Ackerman
Journal:  Front Immunol       Date:  2021-10-12       Impact factor: 7.561

9.  New agents for the treatment of lymphoid leukemia and lymphoma: focus on recent FDA approvals.

Authors:  Andreea Lucia Stancu; Mitchell R Smith; Alexandru Almasan
Journal:  Discoveries (Craiova)       Date:  2014 Jan-Mar

Review 10.  Perspectives for Glyco-Engineering of Recombinant Biopharmaceuticals from Microalgae.

Authors:  Lorenzo Barolo; Raffaela M Abbriano; Audrey S Commault; Jestin George; Tim Kahlke; Michele Fabris; Matthew P Padula; Angelo Lopez; Peter J Ralph; Mathieu Pernice
Journal:  Cells       Date:  2020-03-05       Impact factor: 6.600
  10 in total

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