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Review
. 2018 Jun;11(6):549-559.
doi: 10.1080/17512433.2018.1478725. Epub 2018 Jun 11.

Gemtuzumab ozogamicin for the treatment of acute myeloid leukemia

Jeffrey Baron  1 , Eunice S Wang  2
Affiliations
Review

Gemtuzumab ozogamicin for the treatment of acute myeloid leukemia

Jeffrey Baron et al. Expert Rev Clin Pharmacol. 2018 Jun.

Abstract

Gemtuzumab ozogamicin (GO) is an antibody-drug conjugate consisting of a monoclonal antibody targeting CD33 linked to a cytotoxic derivative of calicheamicin. Despite the known clinical efficacy in relapsed/refractory acute myeloid leukemia (AML), GO was withdrawn from the market in 2010 due to increased early deaths witnessed in newly diagnosed AML patients receiving GO + intensive chemotherapy. In 2017, new data on the clinical efficacy and safety of GO administered on a fractionated-dosing schedule led to re-approval for newly diagnosed and relapsed/refractory AML. Areas covered: Addition of fractionated GO to chemotherapy significantly improved event-free survival of newly diagnosed AML patients with favorable and intermediate cytogenetic-risk disease. GO monotherapy also prolonged survival in newly diagnosed unfit patients and relapse-free survival in relapsed/refractory AML. This new dosing schedule was associated with decreased incidence of hepatotoxicity, veno-occlusive disease, and early mortality. Expert commentary: GO represents the first drug-antibody conjugate approved (twice) in the United States for AML. Its re-emergence adds a valuable agent back into the armamentarium for AML. The approval of GO as well as three other agents for AML in 2017 highlights the need for rapid cytogenetic and molecular characterization of AML and incorporation into new treatment algorithms.

Keywords: Acute myeloid leukemia; CD33; antibody drug conjugate; fractionated dosing; gemtuzumab ozogamicin.

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Conflict of interest statement

Declaration of Interest

J Baron and ES Wang are advisory board members for Pfizer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Pfizer provided a scientific accuracy review at the request of the journal.

Figures

Figure 1
Figure 1
Proposed treatment landscape for newly diagnosed AML
Figure 2
Figure 2
Proposed treatment landscape for relapsed/refractory AML
See this image and copyright information in PMC

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