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Review
. 2019 Jan-Feb;10(1):68-82.
Epub 2019 Jan 1.

Gemtuzumab Ozogamicin: Back Again

Chris Selby  1 , Lisa R Yacko  2 , Ashley E Glode  3
Affiliations
Review

Gemtuzumab Ozogamicin: Back Again

Chris Selby et al. J Adv Pract Oncol. 2019 Jan-Feb.

Abstract

Despite the recent onslaught of approved medications in oncology, acute myeloid leukemia (AML) has been a disease state bereft of pharmaceutical development for decades. The long-standing first-line regimen, 7 + 3, was developed in 1973. A group of four physicians at Roswell Park Memorial Institute built upon prior combinations of daunorubicin and cytarabine to find the optimal combination of 7 days of cytarabine and 3 days of daunorubicin (Lichtman, 2013). This regimen has undergone multiple modifications and patient performance status-based stratifications, but has remained the first-line therapy for AML for the past 45 years. In September 2017, gemtuzumab ozogamicin returned to market and shortly thereafter was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for AML, to be administered in combination with 7 + 3, and as monotherapy for both newly diagnosed and relapsed patients with acute myeloid leukemia (NCCN, 2018; US Food & Drug Administration, 2017). Gemtuzumab ozogamicin continues to be explored in various leukemia settings and is a welcomed addition to the currently available treatment options for AML.

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Figures

Figure 1
Figure 1
Antibody-drug conjugate (ADC) structure and mechanism of action. The ADC consists of three key components: (A) site-specific monoclonal antibody; (B) cytotoxic drug; and (C) functional linker that binds drug to antibody. ADC mechanism of action: (1) binding of ADC to antigen of cancer cell; (2) internalization of antigen-ADC complex; (3) lysosomal degradation releases drug from antibody; (4) drug causes DNA or microtubule disruption. From "Antibody-drug conjugates: A clinical pharmacy perspective on an emerging cancer therapy," by Jerjian et al., 2016, Pharmacotherapy, 36(1), 99–116. © 2016 Pharmacotherapy Publications, Inc. Reprinted with permission.
Figure 2
Figure 2
Gemtuzumab ozogamicin structure.
Table 1
Table 1
Hematologic Adverse Effects From ALFA-0701 Trial
Table 2
Table 2
Nonhematologic Adverse Effects From ALFA-0701 Trial
Table 3
Table 3
Adverse Effects From AML-19 Trial Reported in > 5% of Patients
Table 4
Table 4
Grade 3 Treatment-Emergent Adverse Events Occurring in > 1% of Patients Enrolled in the MyloFrance-1 Trial
Table 5
Table 5
Ongoing Studies With Gemtuzumab Ozogamicin
See this image and copyright information in PMC

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