Obinutuzumab: First Global Approval

@article{Cameron2013ObinutuzumabFG,
  title={Obinutuzumab: First Global Approval},
  author={Fiona Cameron and Paul L. McCormack},
  journal={Drugs},
  year={2013},
  volume={74},
  pages={147-154}
}
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… 
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We report the first preclinical in vitro and in vivo comparison of GA101 (obinutuzumab), a novel glycoengineered type II CD20 monoclonal antibody, with rituximab and ofatumumab, the two currently
Phase 1 study results of the type II glycoengineered humanized anti-CD20 monoclonal antibody obinutuzumab (GA101) in B-cell lymphoma patients.
TLDR
GA101 was well tolerated and demonstrated encouraging activity in patients with previously treated NHL up to doses of 2000 mg and the best overall response was 43%, with 5 complete responses and 4 partial responses.
Safety and Efficacy Of Obinutuzumab (GA101) With Fludarabine/Cyclophosphamide (G-FC) Or Bendamustine (G-B) In The Initial Therapy Of Patients With Chronic Lymphocytic Leukemia (CLL): Results From The Phase 1b Galton Trial (GAO4779g)
TLDR
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TLDR
This phase I study demonstrated that GA101 has an acceptable safety profile and offers encouraging activity to Japanese patients with relapsed/refractory B‐cell non‐Hodgkin lymphoma.
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TLDR
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TLDR
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TLDR
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TLDR
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TLDR
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TLDR
Odinutuzumab induction and maintenance therapy was well tolerated with promising efficacy in this heterogeneous, highly pretreated population and warrants further investigation.
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