Difference between revisions of "Ublituximab (Briumvi)"

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=Mechanism of action=
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==Mechanism of action==
 
From the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=670500 NCI Drug Dictionary]: A chimeric recombinant IgG1 monoclonal antibody directed against human CD20 with potential antineoplastic activity. Ublituximab specifically binds to the B cell-specific cell surface antigen CD20, thereby potentially inducing a B cell-directed complement dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) against CD20-expressing B cells, leading to B cell apoptosis. CD20 is a non-glycosylated cell surface phosphoprotein that is exclusively expressed on B cells during most stages of B cell development and is often overexpressed in B-cell malignancies. Ublituximab has a specific glycosylation profile, with a low fucose content, that may enhance its ADCC response against malignant B cells.
 
From the [https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=670500 NCI Drug Dictionary]: A chimeric recombinant IgG1 monoclonal antibody directed against human CD20 with potential antineoplastic activity. Ublituximab specifically binds to the B cell-specific cell surface antigen CD20, thereby potentially inducing a B cell-directed complement dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) against CD20-expressing B cells, leading to B cell apoptosis. CD20 is a non-glycosylated cell surface phosphoprotein that is exclusively expressed on B cells during most stages of B cell development and is often overexpressed in B-cell malignancies. Ublituximab has a specific glycosylation profile, with a low fucose content, that may enhance its ADCC response against malignant B cells.
  
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=Preliminary data=
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==Diseases for which it is used==
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==[[Chronic_lymphocytic_leukemia_(CLL)_and_Small_lymphocytic_lymphoma_(SLL)|CLL]]==
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*[[Chronic_lymphocytic_leukemia_(CLL)_and_Small_lymphocytic_lymphoma_(SLL)|CLL]]
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# Sharman JP, Farber CM, Mahadevan D, Schreeder MT, Brooks HD, Kolibaba KS, Fanning S, Klein L, Greenwald DR, Sportelli P, Miskin HP, Weiss MS, Burke JM. Ublituximab (TG-1101), a novel glycoengineered anti-CD20 antibody, in combination with ibrutinib is safe and highly active in patients with relapsed and/or refractory chronic lymphocytic leukaemia: results of a phase 2 trial. Br J Haematol. 2017 Feb;176(3):412-420. Epub 2016 Dec 16.[https://onlinelibrary.wiley.com/doi/10.1111/bjh.14447 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27982425 PubMed]
 
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# Sawas A, Farber CM, Schreeder MT, Khalil MY, Mahadevan D, Deng C, Amengual JE, Nikolinakos PG, Kolesar JM, Kuhn JG, Sportelli P, Miskin HP, O'Connor OA. A phase 1/2 trial of ublituximab, a novel anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab. Br J Haematol. 2017 Apr;177(2):243-253. Epub 2017 Feb 21. [https://onlinelibrary.wiley.com/doi/10.1111/bjh.14534 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28220479 PubMed]
 
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# '''Abstract:''' Jeff Porter Sharman, Danielle M. Brander, Anthony R. Mato, Suman Kambhampati, John M. Burke, Frederick Lansigan, Marshall T. Schreeder, Scott D. Lunin, Nilanjan Ghosh, Alexander Zweibach, Mikhail Shtivelband, Patrick M. Travis, Jason Claud Chandler, Kathryn S. Kolibaba, Peter Sportelli, Hari P. Miskin, Michael S. Weiss, and Ian Flinn. Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE phase 3 study. Journal of Clinical Oncology 2017 35:15_suppl, 7504-7504 [https://doi.org/10.1200/JCO.2017.35.15_suppl.7504 link to abstract]
 
  
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=Also known as=
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==History of changes in FDA indication==
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''No antineoplastic indication, at this time.''
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*2023-01-06: Approved for the treatment of relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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==Also known as==
 
*'''Code names:''' LFB-R603, TG-20, TG-1101, TGTX-1101
 
*'''Code names:''' LFB-R603, TG-20, TG-1101, TGTX-1101
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*'''Generic name:''' ublituximab-xiiy
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*'''Brand name:''' Briumvi
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
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[[Category:Anti-CD20 antibodies]]
 
[[Category:Anti-CD20 antibodies]]
  
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[[Category:Chronic lymphocytic leukemia medications (investigational)]]
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[[Category:Chronic lymphocytic leukemia medications]]
  
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[[Category:Investigational drugs]]
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[[Category:FDA approved in 2023]]

Latest revision as of 01:28, 13 January 2024

Mechanism of action

From the NCI Drug Dictionary: A chimeric recombinant IgG1 monoclonal antibody directed against human CD20 with potential antineoplastic activity. Ublituximab specifically binds to the B cell-specific cell surface antigen CD20, thereby potentially inducing a B cell-directed complement dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) against CD20-expressing B cells, leading to B cell apoptosis. CD20 is a non-glycosylated cell surface phosphoprotein that is exclusively expressed on B cells during most stages of B cell development and is often overexpressed in B-cell malignancies. Ublituximab has a specific glycosylation profile, with a low fucose content, that may enhance its ADCC response against malignant B cells.

Diseases for which it is used

History of changes in FDA indication

No antineoplastic indication, at this time.

  • 2023-01-06: Approved for the treatment of relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Also known as

  • Code names: LFB-R603, TG-20, TG-1101, TGTX-1101
  • Generic name: ublituximab-xiiy
  • Brand name: Briumvi
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