Gemtuzumab ozogamicin (Mylotarg)

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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, 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 Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

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Gemtuzumab ozogamicin was withdrawn from the market from 2010-2017; these references will be moved back to active page(s).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.


  1. 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. link to original article PubMed
  2. 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. link to original article PubMed
  3. 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 link to original abstract
  4. 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. link to original article PubMed
  5. 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. link to original article link to PMC article PubMed

Patient drug information

History of changes in FDA indication

  • 5/17/2000: Granted FDA 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.
  • 10/15/2010: Withdrawn from US market[4]
  • 9/1/2017: New FDA approval "for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory 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."


  1. 1.0 1.1 Gemtuzumab ozogamicin (Mylotarg) package insert
  2. Gemtuzumab ozogamicin (Mylotarg) package insert (locally hosted backup)
  3. Gemtuzumab ozogamicin (Mylotarg) patient drug information (Chemocare)
  4. Pfizer letter to healthcare providers (6/21/2010)