Difference between revisions of "Inotuzumab ozogamicin (Besponsa)"

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m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information")
 
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==General information==
 
==General information==
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Class/mechanism: Antibody targeting CD22, conjugated with a cytotoxic, antitumor antibiotic (calicheamicin). Inotuzumab demonstrates a dose-dependent cytotoxicity both in vitro and in vivo. <ref>[http://clinicaltrials.gov/show/NCT01363297 ClinicalTrials.Gov website]</ref>
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Class/mechanism: Antibody targeting CD22, conjugated with a cytotoxic, antitumor antibiotic (calicheamicin). Inotuzumab demonstrates a dose-dependent cytotoxicity both in vitro and in vivo. <ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=9503 Inotuzumab ozogamicin (Besponsa) package insert]</ref><ref>[[:File:Inotuzumabozogamicin.pdf | Inotuzumab ozogamicin (Besponsa) package insert (locally hosted backup)]]</ref><ref>[https://www.besponsa.com/ Besponsa manufacturer's website]</ref><ref>[https://clinicaltrials.gov/study/NCT01363297 NCT01363297] ClinicalTrials.Gov website]</ref>
 
<br>Route: IV
 
<br>Route: IV
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<br>Extravasation: No information.
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<br>Extravasation: No information
  
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For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.
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For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information<ref name="insert"></ref>.
  
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==Preliminary data==
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==Diseases for which it is used==
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*[[B-cell acute lymphoblastic leukemia]]
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*[[Follicular lymphoma]]
  
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===[[Acute lymphocytic leukemia]]===
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==Diseases for which it was used==
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# Kantarjian H, Thomas D, Jorgensen J, Jabbour E, Kebriaei P, Rytting M, York S, Ravandi F, Kwari M, Faderl S, Rios MB, Cortes J, Fayad L, Tarnai R, Wang SA, Champlin R, Advani A, O'Brien S. Inotuzumab ozogamicin, an anti-CD22-calecheamicin conjugate, for refractory and relapsed acute lymphocytic leukaemia: a phase 2 study. Lancet Oncol. 2012 Apr;13(4):403-11. Epub 2012 Feb 21. [http://www.sciencedirect.com/science/article/pii/S1470204511703862 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/22357140 PubMed]
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*[[Diffuse large B-cell lymphoma - historical|Diffuse large B-cell lymphoma]]
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# '''Abstract:''' Susan O'Brien, Deborah A. Thomas, Elias Jabbour, Stefan Faderl, Farhad Ravandi, Gautam Borthakur, Sergernne York, Rebecca Garris, Jorge E. Cortes, Hagop M. Kantarjian. Inotuzumab Ozogamicin In Combination With Low-Intensity Chemotherapy (Mini-hyper-CVD) As Frontline Therapy For Older Patients (≥60 years) With Acute Lymphoblastic Leukemia (ALL). Blood Nov 2013,122(21)1432 [http://bloodjournal.hematologylibrary.org/content/122/21/1432 link to original abstract]
 
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# Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gökbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. Epub 2016 Jun 12. [http://www.nejm.org/doi/full/10.1056/NEJMoa1509277 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27292104 PubMed]
 
  
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===[[Diffuse large B-cell lymphoma]]===
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==Patient drug information==
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# Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Giné E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. Epub 2013 Jan 7. [http://jco.ascopubs.org/content/31/5/573.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/23295790 PubMed]
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*[http://labeling.pfizer.com/ShowLabeling.aspx?id=9503 Inotuzumab ozogamicin (Besponsa) package insert]<ref name="insert"></ref>
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*[https://chemocare.com/druginfo/inotuzumab-ozogamicin.aspx Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/inotuzumab-ozogamicin.aspx Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)]</ref>
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==History of changes in FDA indication==
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*2017-08-17: Approved for the treatment of adults with relapsed or refractory [[B-cell acute lymphoblastic leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]]. ''(Based on INO-VATE ALL)''
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*2024-03-06: Approved for pediatric patients 1 year and older with relapsed or refractory CD22-positive [[B-cell acute lymphoblastic leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]].
  
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===[[Follicular lymphoma]]===
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==History of changes in EMA indication==
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# Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Giné E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. Epub 2013 Jan 7. [http://jco.ascopubs.org/content/31/5/573.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/23295790 PubMed]
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*2017-06-28: Initial authorization
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# Goy A, Forero A, Wagner-Johnston N, Christopher Ehmann W, Tsai M, Hatake K, Ananthakrishnan R, Volkert A, Vandendries E, Ogura M. A phase 2 study of inotuzumab ozogamicin in patients with indolent B-cell non-Hodgkin lymphoma refractory to rituximab alone, rituximab and chemotherapy, or radioimmunotherapy. Br J Haematol. 2016 Aug;174(4):571-81. Epub 2016 Apr 22. [http://onlinelibrary.wiley.com/wol1/doi/10.1111/bjh.14094/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27101934 PubMed]
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==History of changes in Health Canada indication==
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*2018-03-15: Initial notice of compliance as monotherapy for the treatment of adults with relapsed or refractory CD22-positive [[B-cell acute lymphoblastic leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]].
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==History of changes in PMDA indication==
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*2018-01-19: New approval for the treatment of relapsed or refractory CD22-positive [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]].
  
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==Patient drug information==
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==Also known as==
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No information available.
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*'''Code name:''' CMC-544
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*'''Brand name:''' Besponsa
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
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[[Category:Drug index]]
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[[Category:Drugs]]
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[[Category:Chemotherapy]]
 
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
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[[Category:Protein expression-specific medications]]
  
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[[Category:Antibody medications]]
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[[Category:Anti-CD22 antibody-drug conjugates]]
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[[Category:Antibody-drug conjugates]]
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[[Category:Enediyne antibiotic]]
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[[Category:Anti-CD22 antibodies]]
 
  
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[[Category:Acute lymphocytic leukemia medications]]
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[[Category:B-cell acute lymphoblastic leukemia medications]]
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[[Category:Diffuse large B-cell lymphoma medications]]
 
 
[[Category:Follicular lymphoma medications]]
 
[[Category:Follicular lymphoma medications]]
  
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[[Category:Investigational]]
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[[Category:Diffuse large B-cell lymphoma medications (historic)]]
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[[Category:EMA approved in 2017]]
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[[Category:FDA approved in 2017]]
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[[Category:Health Canada approved in 2018]]
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[[Category:PMDA approved in 2018]]
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[[Category:Pfizer product]]

Latest revision as of 00:59, 29 June 2024

General information

Class/mechanism: Antibody targeting CD22, conjugated with a cytotoxic, antitumor antibiotic (calicheamicin). Inotuzumab demonstrates a dose-dependent cytotoxicity both in vitro and in vivo. [1][2][3][4]
Route: IV
Extravasation: No information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information[1].

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 2017-06-28: Initial authorization

History of changes in Health Canada indication

History of changes in PMDA indication

Also known as

  • Code name: CMC-544
  • Brand name: Besponsa

References

  1. ↑ 1.0 1.1 1.2 Inotuzumab ozogamicin (Besponsa) package insert
  2. ↑ Inotuzumab ozogamicin (Besponsa) package insert (locally hosted backup)
  3. ↑ Besponsa manufacturer's website
  4. ↑ NCT01363297 ClinicalTrials.Gov website]
  5. ↑ Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)
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