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Tositumomab
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<h2 id="clinical-use">Clinical use</h2> <p>A personalized regimen using Bexxar was approved for the treatment of relapsed or <a href="/facts/Chemotherapy/fWTLbaUT">chemotherapy</a>/<a href="/facts/Rituxan/q6BLRsS6">rituxan</a>-<a href="/facts/Refractory/LoKrzGkR">refractory</a> <a href="/facts/Non-Hodgkin_lymphoma/KIFxt74F">Non-Hodgkin lymphoma</a> in 2003.<a class="footnote-ref" id="fnref:9" href="#fn:9"><sup>9</sup></a><a class="footnote-ref" id="fnref:10" href="#fn:10"><sup>10</sup></a><a class="footnote-ref" id="fnref:11" href="#fn:11"><sup>11</sup></a> </p><p>The radioactive dose was adjusted for each patient in order to maximize the radiation delivered to the tumor and minimize the exposure of other organs.<a class="footnote-ref" id="fnref:12" href="#fn:12"><sup>12</sup></a><a class="footnote-ref" id="fnref:13" href="#fn:13"><sup>13</sup></a>: 14–15 Bexxar combined separate administration of unlabelled and iodine-labelled (i.e. <a href="/facts/Covalently_bonded/EzMLf3Pz">covalently bonded</a> to 131I) tositumomab. A first dose of labelled antibody was given once, and whole-body radiation was measured with a <a href="/facts/Gamma_camera/coGxuajk">gamma camera</a> 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.<a class="footnote-ref" id="fnref:14" href="#fn:14"><sup>14</sup></a><a class="footnote-ref" id="fnref:15" href="#fn:15"><sup>15</sup></a>: 14–15 Each time the labelled antibody was administered, it was always preceded by unlabelled (non-radioactive) antibody. Early <a href="/facts/Clinical_trial/q8LMr832">clinical trials</a> 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.<a class="footnote-ref" id="fnref:16" href="#fn:16"><sup>16</sup></a>: 21 </p> <h2 id="availability">Availability</h2> <h3>United States</h3> <p>Following a first <a href="/facts/Investigational_new_drug/GTHo92ee">investigational new drug</a> application in 1989 and <a href="/facts/Biologics_license_application/KHGqbmy6">biologics license application</a> in 2000, Bexxar was approved by the <a href="/facts/FDA/fMfdaRAa">FDA</a> in 2003.<a class="footnote-ref" id="fnref:17" href="#fn:17"><sup>17</sup></a><a class="footnote-ref" id="fnref:18" href="#fn:18"><sup>18</sup></a> Sale of Bexxar was discontinued and marketing approval was withdrawn in February 2014 due to a decline in usage (fewer than 75 patients in 2012). One possible explanation for the lack of demand, despite a claimed 70% response rate, was that <a href="/facts/Oncologist/t2CUAEJQ">oncologists</a> could not sell it directly to patients but had to refer patients to third party specialist centers, however a "muddled clinical trials strategy", supply chain issues, reimbursement problems, and emergence of non-radioactive competitors has also been blamed.<a class="footnote-ref" id="fnref:19" href="#fn:19"><sup>19</sup></a><a class="footnote-ref" id="fnref:20" href="#fn:20"><sup>20</sup></a><a class="footnote-ref" id="fnref:21" href="#fn:21"><sup>21</sup></a> </p> <h3>Europe</h3> <p>The <a href="/facts/European_Medicines_Agency/h9FTtCYc">European Medicines Agency</a> granted tositumomab and 131I-tositumomab <a href="/facts/Orphan_drug_status/96judAS6">orphan drug status</a>, for the treatment of <a href="/facts/Follicular_lymphoma/Ntaq19Ea">follicular lymphoma</a>, to <a href="/facts/Amersham_plc/7F912t7l">Amersham plc</a> in 2003. This was withdrawn in October 2015 at the request of the new owner, GlaxoSmithKline.<a class="footnote-ref" id="fnref:22" href="#fn:22"><sup>22</sup></a><a class="footnote-ref" id="fnref:23" href="#fn:23"><sup>23</sup></a> </p> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>"BEXXAR drug label" (PDF). FDA. GlaxoSmithKline. August 2012. Retrieved 18 January 2016. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>"BEXXAR drug label" (PDF). FDA. GlaxoSmithKline. August 2012. Retrieved 18 January 2016. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>"BEXXAR drug label" (PDF). FDA. GlaxoSmithKline. August 2012. Retrieved 18 January 2016. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> <li id="fn:4"><p>"Guide to Antibody structure and isotypes". Abcam. Retrieved 25 July 2020. <a href="https://www.abcam.com/protocols/antibody-structure-and-isotypes" target="_blank">https://www.abcam.com/protocols/antibody-structure-and-isotypes</a> <a href="#fnref:4" class="footnote-back-ref">↩</a></p></li> <li id="fn:5"><p>Mozee, Carla (29 April 2005). "Glaxo to acquire Corixa for $300 million". MarketWatch. <a href="https://www.marketwatch.com/story/corixa-agrees-to-glaxo-acquisition-for-300-million" target="_blank">https://www.marketwatch.com/story/corixa-agrees-to-glaxo-acquisition-for-300-million</a> <a href="#fnref:5" class="footnote-back-ref">↩</a></p></li> <li id="fn:6"><p>Srinivasan A, Mukherji SK (April 2011). "Tositumomab and iodine I 131 tositumomab (Bexaar)". AJNR. American Journal of Neuroradiology. 32 (4): 637–8. doi:10.3174/ajnr.A2593. PMC 7965875. PMID 21436340. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7965875" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7965875</a> <a href="#fnref:6" class="footnote-back-ref">↩</a></p></li> <li id="fn:7"><p>Davies, A J (28 May 2007). "Radioimmunotherapy for B-cell lymphoma: Y90 ibritumomab tiuxetan and I131 tositumomab". Oncogene. 26 (25): 3614–3628. doi:10.1038/sj.onc.1210378. PMID 17530015. <a href="https://doi.org/10.1038%2Fsj.onc.1210378" target="_blank">https://doi.org/10.1038%2Fsj.onc.1210378</a> <a href="#fnref:7" class="footnote-back-ref">↩</a></p></li> <li id="fn:8"><p>Timmerman, Luke (26 August 2013). "Why Good Drugs Sometimes Fail: The Bexxar Story". Xconomy. <a href="http://www.xconomy.com/national/2013/08/26/why-good-drugs-sometimes-fail-in-the-market-the-bexxar-story/" target="_blank">http://www.xconomy.com/national/2013/08/26/why-good-drugs-sometimes-fail-in-the-market-the-bexxar-story/</a> <a href="#fnref:8" class="footnote-back-ref">↩</a></p></li> <li id="fn:9"><p>Srinivasan A, Mukherji SK (April 2011). "Tositumomab and iodine I 131 tositumomab (Bexaar)". AJNR. American Journal of Neuroradiology. 32 (4): 637–8. doi:10.3174/ajnr.A2593. PMC 7965875. PMID 21436340. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7965875" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7965875</a> <a href="#fnref:9" class="footnote-back-ref">↩</a></p></li> <li id="fn:10"><p>"Corixa and Glaxo's Cancer Drug Wins F.D.A. Approval". The New York Times. 1 July 2003. ISSN 0362-4331.New York Times. July 1, 2003 Company News: Corixa and Glaxo's Cancer Drug Wins FDA Approval <a href="https://www.nytimes.com/2003/07/01/business/company-news-corixa-and-glaxo-s-cancer-drug-wins-fda-approval.html" target="_blank">https://www.nytimes.com/2003/07/01/business/company-news-corixa-and-glaxo-s-cancer-drug-wins-fda-approval.html</a> <a href="#fnref:10" class="footnote-back-ref">↩</a></p></li> <li id="fn:11"><p>"Tositumomab - Product Approval Information - Licensing Action". FDA/Center for Drug Evaluation and Research. 2 July 2003. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/tosicor062703L.htm" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/tosicor062703L.htm</a> <a href="#fnref:11" class="footnote-back-ref">↩</a></p></li> <li id="fn:12"><p>"BEXXAR drug label" (PDF). FDA. GlaxoSmithKline. August 2012. Retrieved 18 January 2016. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf</a> <a href="#fnref:12" class="footnote-back-ref">↩</a></p></li> <li id="fn:13"><p>"Tositumomab product description". Food and Drug Administration. Archived from the original on 27 January 2018. Retrieved 25 July 2020. <a href="https://web.archive.org/web/20180127032045/https://www.fda.gov/ohrms/dockets/ac/02/briefing/3916B1_02_D-FDA%20-%20Product%20Description.htm" target="_blank">https://web.archive.org/web/20180127032045/https://www.fda.gov/ohrms/dockets/ac/02/briefing/3916B1_02_D-FDA%20-%20Product%20Description.htm</a> <a href="#fnref:13" class="footnote-back-ref">↩</a></p></li> <li id="fn:14"><p>"BEXXAR drug label" (PDF). FDA. GlaxoSmithKline. August 2012. Retrieved 18 January 2016. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf</a> <a href="#fnref:14" class="footnote-back-ref">↩</a></p></li> <li id="fn:15"><p>"Tositumomab product description". Food and Drug Administration. Archived from the original on 27 January 2018. Retrieved 25 July 2020. <a href="https://web.archive.org/web/20180127032045/https://www.fda.gov/ohrms/dockets/ac/02/briefing/3916B1_02_D-FDA%20-%20Product%20Description.htm" target="_blank">https://web.archive.org/web/20180127032045/https://www.fda.gov/ohrms/dockets/ac/02/briefing/3916B1_02_D-FDA%20-%20Product%20Description.htm</a> <a href="#fnref:15" class="footnote-back-ref">↩</a></p></li> <li id="fn:16"><p>"Tositumomab product description". Food and Drug Administration. Archived from the original on 27 January 2018. Retrieved 25 July 2020. <a href="https://web.archive.org/web/20180127032045/https://www.fda.gov/ohrms/dockets/ac/02/briefing/3916B1_02_D-FDA%20-%20Product%20Description.htm" target="_blank">https://web.archive.org/web/20180127032045/https://www.fda.gov/ohrms/dockets/ac/02/briefing/3916B1_02_D-FDA%20-%20Product%20Description.htm</a> <a href="#fnref:16" class="footnote-back-ref">↩</a></p></li> <li id="fn:17"><p>"Briefing Information Iodine I-131 Tositumomab". Food and Drug Administration. 17 December 2002. Archived from the original on 25 January 2018. Retrieved 25 July 2020. <a href="https://web.archive.org/web/20180125201355/https://www.fda.gov/ohrms/dockets/ac/02/briefing/3916b1.htm" target="_blank">https://web.archive.org/web/20180125201355/https://www.fda.gov/ohrms/dockets/ac/02/briefing/3916b1.htm</a> <a href="#fnref:17" class="footnote-back-ref">↩</a></p></li> <li id="fn:18"><p>"Tositumomab - Product Approval Information - Licensing Action". FDA/Center for Drug Evaluation and Research. 2 July 2003. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/tosicor062703L.htm" target="_blank">https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/tosicor062703L.htm</a> <a href="#fnref:18" class="footnote-back-ref">↩</a></p></li> <li id="fn:19"><p>Timmerman, Luke (26 August 2013). "Why Good Drugs Sometimes Fail: The Bexxar Story". Xconomy. <a href="http://www.xconomy.com/national/2013/08/26/why-good-drugs-sometimes-fail-in-the-market-the-bexxar-story/" target="_blank">http://www.xconomy.com/national/2013/08/26/why-good-drugs-sometimes-fail-in-the-market-the-bexxar-story/</a> <a href="#fnref:19" class="footnote-back-ref">↩</a></p></li> <li id="fn:20"><p>Davies, A J (28 May 2007). "Radioimmunotherapy for B-cell lymphoma: Y90 ibritumomab tiuxetan and I131 tositumomab". Oncogene. 26 (25): 3614–3628. doi:10.1038/sj.onc.1210378. PMID 17530015. <a href="https://doi.org/10.1038%2Fsj.onc.1210378" target="_blank">https://doi.org/10.1038%2Fsj.onc.1210378</a> <a href="#fnref:20" class="footnote-back-ref">↩</a></p></li> <li id="fn:21"><p>"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". Federal Register. 23 October 2013. (78 FR 63226) <a href="https://www.federalregister.gov/documents/2013/10/23/2013-24840/glaxosmithkline-llc-withdrawal-of-approval-of-the-indication-for-treatment-of-patients-with-relapsed" target="_blank">https://www.federalregister.gov/documents/2013/10/23/2013-24840/glaxosmithkline-llc-withdrawal-of-approval-of-the-indication-for-treatment-of-patients-with-relapsed</a> <a href="#fnref:21" class="footnote-back-ref">↩</a></p></li> <li id="fn:22"><p>"EU/3/03/137". European Medicines Agency. 17 September 2018. Retrieved 25 July 2020. <a href="https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu303137" target="_blank">https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu303137</a> <a href="#fnref:22" class="footnote-back-ref">↩</a></p></li> <li id="fn:23"><p>"EU/3/03/136". European Medicines Agency. 17 September 2018. Retrieved 25 July 2020. <a href="https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu303136" target="_blank">https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu303136</a> <a href="#fnref:23" class="footnote-back-ref">↩</a></p></li> </ol>