Difference between revisions of "Gemtuzumab ozogamicin (Mylotarg)"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m (Text replacement - "manufacturer. Instead" to "manufacturer. Instead")
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")
 
(32 intermediate revisions by 3 users not shown)
Line 1: Line 1:
 
==General information==
 
==General information==
−
Class/mechanism: Antibody-cytotoxic agent conjugate. Gemtuzumab ozogamicin is comprised of a recombinant humanized IgG4 kappa antibody against CD33--an adhesion protein expressed on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells--conjugated with a cytotoxic agent, calicheamicin. The antibody-cytotoxic agent is internalized after binding, and the calicheamicin derivative binds to DNA in the minor groove, causing DNA double strand breaks and cell death.<ref name="insert">[http://labeling.pfizer.com/showlabeling.aspx?id=119 Gemtuzumab ozogamicin (Mylotarg) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/gemtuzumabozogamicin.pdf Gemtuzumab ozogamicin (Mylotarg) package insert (locally hosted backup)]</ref>
+
Class/mechanism: Antibody-cytotoxic agent conjugate. Gemtuzumab ozogamicin is comprised of a recombinant humanized IgG4 kappa antibody against CD33--an adhesion protein expressed on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells--conjugated with a cytotoxic agent, calicheamicin. The antibody-cytotoxic agent is internalized after binding, and the calicheamicin derivative binds to DNA in the minor groove, causing DNA double strand breaks and cell death.<ref name="insert">[http://labeling.pfizer.com/showlabeling.aspx?id=119 Gemtuzumab ozogamicin (Mylotarg) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/gemtuzumabozogamicin.pdf Gemtuzumab ozogamicin (Mylotarg) package insert (locally hosted backup)]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: no information
 
<br>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 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.<ref name="insert"></ref>
+
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>
  
 +
==Diseases for which it is established==
 +
*[[Acute myeloid leukemia]]
 
==Diseases for which it is used==
 
==Diseases for which it is used==
−
''Gemtuzumab ozogamicin was withdrawn from the market from 2010-2017; these references will be moved back to active page(s). To be completed.''
 
−
 
−
*[[Acute myeloid leukemia]]
 
−
 
−
===References===
 
−
# Sievers EL, Larson RA, Stadtmauer EA, Estey E, Löwenberg B, Dombret H, Karanes C, Theobald M, Bennett JM, Sherman ML, Berger MS, Eten CB, Loken MR, van Dongen JJ, Bernstein ID, Appelbaum FR; Mylotarg Study Group. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol. 2001 Jul 1;19(13):3244-54. [http://jco.ascopubs.org/content/19/13/3244.long link to original article]  [https://www.ncbi.nlm.nih.gov/pubmed/11432892 PubMed]
 
−
# Castaigne S, Pautas C, Terré C, Raffoux E, Bordessoule D, Bastie JN, Legrand O, Thomas X, Turlure P, Reman O, de Revel T, Gastaud L, de Gunzburg N, Contentin N, Henry E, Marolleau JP, Aljijakli A, Rousselot P, Fenaux P, Preudhomme C, Chevret S, Dombret H; Acute Leukemia French Association. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012 Apr 21;379(9825):1508-16. [https://www.ncbi.nlm.nih.gov/pubmed/22482940 PubMed]
 
−
# Petersdorf SH, Kopecky KJ, Slovak M, Willman C, Nevill T, Brandwein J, Larson RA, Erba HP, Stiff PJ, Stuart RK, Walter RB, Tallman MS, Stenke L, Appelbaum FR. A phase 3 study of gemtuzumab ozogamicin during induction and postconsolidation therapy in younger patients with acute myeloid leukemia. Blood. 2013 Jun 13;121(24):4854-60. Epub 2013 Apr 16. [http://bloodjournal.hematologylibrary.org/content/121/24/4854.long link to original article]  [https://www.ncbi.nlm.nih.gov/pubmed/23591789 PubMed]
 
−
# '''Abstract:''' '''Meta-analysis:''' Stephen Petersdorf, Elihu H. Estey, Megan Othus, Frederick R. Appelbaum, Sylvie Castaigne, Herve Dombret, Sylvie Chevret, Jacques Delaunay, Norbert Ifrah, Jean-Yves Cahn, Christian Recher, Alan K Burnett. The Addition Of Gemtuzumab Ozogamicin (GO) To Induction Chemotherapy Reduces Relapse and Improves Survival In Patients Without Adverse Risk Karyotype: Results Of An Individual Patient Meta-Analysis Of The Five Randomised Trials. Blood Nov 2013,122(21)356 [http://bloodjournal.hematologylibrary.org/content/122/21/356 link to original abstract]
 
−
<!-- Presented in part at the 56th Annual Meeting of the American Society of Hematology, San Francisco, CA, December 6-9, 2014. -->
 
−
# Amadori S, Suciu S, Selleslag D, Aversa F, Gaidano G, Musso M, Annino L, Venditti A, Voso MT, Mazzone C, Magro D, De Fabritiis P, Muus P, Alimena G, Mancini M, Hagemeijer A, Paoloni F, Vignetti M, Fazi P, Meert L, Ramadan SM, Willemze R, de Witte T, Baron F. Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial. J Clin Oncol. 2016 Mar 20;34(9):972-9. Epub 2016 Jan 25. [http://jco.ascopubs.org/content/34/9/972.full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26811524 PubMed]
 
−
# '''GO-A-HAM:''' Hütter-Krönke ML, Benner A, Döhner K, Krauter J, Weber D, Moessner M, Köhne CH, Horst HA, Schmidt-Wolf IG, Rummel M, Götze K, Koller E, Petzer AL, Salwender H, Fiedler W, Kirchen H, Haase D, Kremers S, Theobald M, Matzdorff AC, Ganser A,  Döhner H, Schlenk RF. Salvage therapy with high-dose cytarabine and mitoxantrone in combination with all-trans retinoic acid and gemtuzumab ozogamicin in acute myeloid leukemia refractory to first induction therapy. Haematologica. 2016 Jul;101(7):839-45. Epub 2016 Apr 1. [http://www.haematologica.org/content/101/7/839 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/27036160/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/27036160 PubMed]
 
−
 
 
*[[Acute promyelocytic leukemia]]
 
*[[Acute promyelocytic leukemia]]
  
 
==Patient drug information==
 
==Patient drug information==
 +
*[http://labeling.pfizer.com/showlabeling.aspx?id=119 Gemtuzumab ozogamicin (Mylotarg) package insert]<ref name="insert"></ref>
 
*[http://www.chemocare.com/bio/gemtuzumab_ozogamicin.asp Gemtuzumab ozogamicin (Mylotarg) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/bio/gemtuzumab_ozogamicin.asp Gemtuzumab ozogamicin (Mylotarg) patient drug information (Chemocare)]</ref>
 
*[http://www.chemocare.com/bio/gemtuzumab_ozogamicin.asp Gemtuzumab ozogamicin (Mylotarg) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/bio/gemtuzumab_ozogamicin.asp Gemtuzumab ozogamicin (Mylotarg) patient drug information (Chemocare)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*5/17/2000: Granted FDA accelerated approval for the treatment of patients with [[Acute myeloid leukemia | CD33 positive acute myeloid leukemia]] in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy.
+
*2000-05-17: Granted accelerated approval for the treatment of patients with [[Biomarkers#CD33|CD33]] [[Biomarkers#Expression|positive]] [[Acute myeloid leukemia | acute myeloid leukemia]] in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. ''(Based on GO study 1, GO study 2, and GO study 3)''
−
*10/15/2010: '''Withdrawn from US market'''<ref>[http://www.pfizer.com/files/products/mylotarg_hcp_letter.pdf Pfizer letter to healthcare providers (6/21/2010)]</ref>
+
**2011-11-28: Accelerated approval for [[acute myeloid leukemia]] withdrawn. ''(Based on SWOG S0106)''
−
*9/1/2017: New FDA approval "for the treatment of newly-diagnosed [[Acute myeloid leukemia |CD33-positive acute myeloid leukemia (AML)]] in adults and for treatment of relapsed or refractory [[Acute myeloid leukemia |CD33-positive AML]] in adults and in pediatric patients 2 years and older. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients."
+
*2017-09-01: New approval for the treatment of newly-diagnosed [[Biomarkers#CD33|CD33]]-[[Biomarkers#Expression|positive]] [[Acute myeloid leukemia |acute myeloid leukemia (AML)]] in adults. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML. ''(Based on ALFA-0701 and EORTC/GIMEMA AML-19)''
 +
*2017-09-01: New approval for treatment of relapsed or refractory [[Biomarkers#CD33|CD33]]-[[Biomarkers#Expression|positive]] [[Acute myeloid leukemia |AML]] in adults and in pediatric patients 2 years and older. ''(Based on MyloFrance-1)''
 +
*2020-06-16: Approved for newly-diagnosed [[Biomarkers#CD33|CD33]]-[[Biomarkers#Expression|positive]] [[Acute myeloid leukemia|acute myeloid leukemia (AML)]] to include pediatric patients 1 month and older. ''(Approval expanded to pediatric patients 1 month and older; based on COG AAML0531)''
 +
 
 +
==History of changes in EMA indication==
 +
*2018-04-19: Marketing authorisation (unclear if this is initial or re-authorisation)
 +
*Uncertain date: Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive [[Acute myeloid leukemia|acute myeloid leukaemia (AML)]], except acute promyelocytic leukaemia (APL). ''(Based on ALFA-0701)''
 +
 
 +
==History of changes in Health Canada indication==
 +
*2019-11-28: Initial notice of compliance
 +
==History of changes in PMDA indication==
 +
*2005-07-25: Initial approval for the treatment of relapsing or intractable CD33 positive [[acute myeloid leukemia]].
 +
==Also known as==
 +
*'''Brand name:''' Mylotarg
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
+
[[Category:Drugs]]
−
[[Category:Chemotherapy]]
 
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
 +
[[Category:Protein expression-specific medications]]
  
−
[[Category:Antibody medications]]
+
[[Category:Anti-CD33 antibody-drug conjugates]]
−
[[Category:Antibody-drug conjugates]]
 
−
[[Category:Anti-CD33 antibodies]]
 
 
[[Category:Enediyne antibiotic]]
 
[[Category:Enediyne antibiotic]]
  
Line 45: Line 46:
 
[[Category:Acute promyelocytic leukemia medications]]
 
[[Category:Acute promyelocytic leukemia medications]]
  
−
[[Category:Discontinued]]
+
[[Category:FDA approved in 2000]]
−
[[Category:Drugs FDA approved in 2000]]
+
[[Category:FDA withdrawn in 2011]]
−
[[Category:Drugs FDA approved in 2017]]
+
[[Category:FDA approved in 2017]]
−
[[Category:FDA approved drugs]]
+
[[Category:EMA approved in 2018]]
 +
[[Category:Health Canada approved in 2019]]
 +
[[Category:PMDA approved in 2005]]

Latest revision as of 01:06, 29 June 2024

General information

Class/mechanism: Antibody-cytotoxic agent conjugate. Gemtuzumab ozogamicin is comprised of a recombinant humanized IgG4 kappa antibody against CD33--an adhesion protein expressed on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells--conjugated with a cytotoxic agent, calicheamicin. The antibody-cytotoxic agent is internalized after binding, and the calicheamicin derivative binds to DNA in the minor groove, causing DNA double strand breaks and cell death.[1][2]
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 established

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 2000-05-17: Granted accelerated approval for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. (Based on GO study 1, GO study 2, and GO study 3)
  • 2017-09-01: New approval for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML. (Based on ALFA-0701 and EORTC/GIMEMA AML-19)
  • 2017-09-01: New approval for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. (Based on MyloFrance-1)
  • 2020-06-16: Approved for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older. (Approval expanded to pediatric patients 1 month and older; based on COG AAML0531)

History of changes in EMA indication

  • 2018-04-19: Marketing authorisation (unclear if this is initial or re-authorisation)
  • Uncertain date: Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL). (Based on ALFA-0701)

History of changes in Health Canada indication

  • 2019-11-28: Initial notice of compliance

History of changes in PMDA indication

  • 2005-07-25: Initial approval for the treatment of relapsing or intractable CD33 positive acute myeloid leukemia.

Also known as

  • Brand name: Mylotarg

References

  1. ↑ 1.0 1.1 1.2 Gemtuzumab ozogamicin (Mylotarg) package insert
  2. ↑ Gemtuzumab ozogamicin (Mylotarg) package insert (locally hosted backup)
  3. ↑ Gemtuzumab ozogamicin (Mylotarg) patient drug information (Chemocare)
Retrieved from "https://hemonc.org/w/index.php?title=Gemtuzumab_ozogamicin_(Mylotarg)&oldid=87399"