Tositumomab: Difference between revisions
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'''Tositumomab''' is a murine IgG2a lambda monoclonal antibody directed against the [[CD20]] antigen, produced in mammalian cells.<ref name=Label> GlaxoSmithKline and FDA> [http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf Bexxar label]. Last updated August 2012. Page accessed January 18, 2016</ref> Combined with [[radioisotope]] [[iodine 131]]<ref name=Timmerman2013/> it was called '''Iodine I 131 Tositumomab'''. Unlabelled tositumomab together with iodine-labelled tositumomab was called '''Bexxar'''<ref name=Label/> and a regimen using Bexxar was approved for the treatment of relapsed or [[chemotherapy]]/[[rituxan]]-[[refractory]] [[Non-Hodgkin lymphoma]] in 2003.<ref>New York Times. July 1, 2003 [http://www.nytimes.com/2003/07/01/business/company-news-corixa-and-glaxo-s-cancer-drug-wins-fda-approval.html Company News: Corixa and Glaxo's Cancer Drug Wins FDA Approval]</ref><ref>[http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/tosicor062703L.htm Product Approval Information - Licensing Action]</ref> |
'''Tositumomab''' is a murine IgG2a lambda monoclonal antibody directed against the [[CD20]] antigen, produced in mammalian cells.<ref name=Label> GlaxoSmithKline and FDA> [http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf Bexxar label]. Last updated August 2012. Page accessed January 18, 2016</ref> Combined with [[radioisotope]] [[iodine 131]]<ref name=Timmerman2013/> it was called '''Iodine I 131 Tositumomab'''. Unlabelled tositumomab together with iodine-labelled tositumomab was called '''Bexxar'''<ref name=Label/> and a personlized regimen using Bexxar was approved for the treatment of relapsed or [[chemotherapy]]/[[rituxan]]-[[refractory]] [[Non-Hodgkin lymphoma]] in 2003.<ref name=Srinivasan2011rev>Srinivasan A, Mukherji SK. Tositumomab and iodine I 131 tositumomab (Bexaar). AJNR Am J Neuroradiol. 2011 Apr;32(4):637-8. PMID 21436340. [http://www.ajnr.org/content/32/4/637.full.pdf+html Free full text]</ref><ref>New York Times. July 1, 2003 [http://www.nytimes.com/2003/07/01/business/company-news-corixa-and-glaxo-s-cancer-drug-wins-fda-approval.html Company News: Corixa and Glaxo's Cancer Drug Wins FDA Approval]</ref><ref>[http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/tosicor062703L.htm Product Approval Information - Licensing Action]</ref> |
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The treatment regimen was personalized for each person receiving the drug in order to maximize the radiation delivered to the tumor and to minimize the amount of radiation to which the person would be exposed.<ref name=Label/><ref name=2002 Descrip>FDA [http://www.fda.gov/ohrms/dockets/ac/02/briefing/3916B1_02_D-FDA%20-%20Product%20Description.pdf Description of the Product]. December 17, 2002. Linked from index page [http://www.fda.gov/ohrms/dockets/ac/02/briefing/3916b1.htm here.</ref>{{rp|14-15}} A first dose of labelled antibody was given once, and whole-body radiation was measured with a [[gamma camera]] over seven days. Analysis of that imaging data allowed an optimal dose of labelled antibody to be calculated, which was then administered once a day, for up to seven days.<ref name=Label/><ref name=2002 Descrip>{{rp|14-15}} Each time the labelled antibody was administered, it was always preceded by unlabelled antibody because early clinical trials had shown that total body residence times of radioactivity were longer in people who first received unlabelled antibody, so that a lower dose of labelled antibody was needed to deliver the required total dose of radiation; additionally labelled antibody targeted tumors better in people pre-treated with unlabelled antibody.<ref name=2002 Descrip/>{{rp|21}} |
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This drug combination was developed by [[Corixa (company)|Corixa]] which was purchased by [[GlaxoSmithKline]]) in 2005.<ref>Carla Mozee for MarketWatch. April 29, 2005 [http://www.marketwatch.com/story/corixa-agrees-to-glaxo-acquisition-for-300-million Glaxo to acquire Corixa for $300 million]</ref> |
This drug combination was developed by [[Corixa (company)|Corixa]] which was purchased by [[GlaxoSmithKline]]) in 2005.<ref>Carla Mozee for MarketWatch. April 29, 2005 [http://www.marketwatch.com/story/corixa-agrees-to-glaxo-acquisition-for-300-million Glaxo to acquire Corixa for $300 million]</ref> |
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Revision as of 20:33, 18 January 2016
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Mouse |
| Target | CD20 |
| Clinical data | |
| Trade names | Bexxar |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a609013 |
| ATC code | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C6416H9874N1688O1987S44 |
| Molar mass | 143859.7 g/mol g·mol−1 |
  (what is this?) (verify) | |
Tositumomab is a murine IgG2a lambda monoclonal antibody directed against the CD20 antigen, produced in mammalian cells.[1] Combined with radioisotope iodine 131[2] it was called Iodine I 131 Tositumomab. Unlabelled tositumomab together with iodine-labelled tositumomab was called Bexxar[1] and a personlized regimen using Bexxar was approved for the treatment of relapsed or chemotherapy/rituxan-refractory Non-Hodgkin lymphoma in 2003.[3][4][5]
The treatment regimen was personalized for each person receiving the drug in order to maximize the radiation delivered to the tumor and to minimize the amount of radiation to which the person would be exposed.[1]Cite error: The <ref> tag has too many names (see the help page).: 14–15 A first dose of labelled antibody was given once, and whole-body radiation was measured with a gamma camera over seven days. Analysis of that imaging data allowed an optimal dose of labelled antibody to be calculated, which was then administered once a day, for up to seven days.[1]Cite error: The <ref> tag has too many names (see the help page).
Sale of Bexxar was discontinued and marketing approval was withdrawn in February 2014 due to the decline in usage (fewer than 75 patients in 2012) and the existence of other similar drugs.[2][6]
References
- ^ a b c d GlaxoSmithKline and FDA> Bexxar label. Last updated August 2012. Page accessed January 18, 2016
- ^ a b "Why Good Drugs Sometimes Fail: The Bexxar Story".
- ^ Srinivasan A, Mukherji SK. Tositumomab and iodine I 131 tositumomab (Bexaar). AJNR Am J Neuroradiol. 2011 Apr;32(4):637-8. PMID 21436340. Free full text
- ^ New York Times. July 1, 2003 Company News: Corixa and Glaxo's Cancer Drug Wins FDA Approval
- ^ Product Approval Information - Licensing Action
- ^ Notice by the Food and Drug Administration on October 23, 2013. GlaxoSmithKline LLC; Withdrawal of Approval of the Indication for Treatment of Patients With Relapsed or Refractory, Low Grade, Follicular, or Transformed CD20 Positive Non-Hodgkin's Lymphoma Who Have Not Received Prior Rituximab; BEXXAR
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