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Mylotarg: Revisiting Its Clinical Potential Post-Withdrawal

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Antibody-Drug Conjugates

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 17))

Abstract

Mylotarg® (gemtuzumab ozogamicin (GO)) was the first antibody–drug conjugate approved for the treatment of acute myeloid leukemia (AML) by the Food and Drug Administration (FDA) via the accelerated approval process in 2000. Mylotarg® consists of an antibody directed toward the CD33 antigen conjugated to the antitumor antibiotic, calicheamicin. Mainly due to concerns about the safety profile and lack of improvement of clinical benefit in post-approval clinical trials, the drug was voluntarily withdrawn by the market by Pfizer in June 2010. Since its withdrawal from the market, results from several clinical trials warrant revisiting the clinical use of the drug when used at a low-dose range in newly diagnosed AML with favorable cytogenetics.

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Authors and Affiliations

  1. Department of Pharmacology and Pharmaceutical Sciences, University of Southern California, Los Angeles, California, USA

    Jennica L. Zaro

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  1. Jennica L. Zaro
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Correspondence to Jennica L. Zaro .

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  1. Western University of Health Sciences, Department of Pharmaceutical Sciences, Pomona, California, USA

    Jeffrey Wang

  2. University of Southern California, Department of Pharmacology and Pharmaceutical Sciences, Los Angeles, California, USA

    Wei-Chiang Shen

  3. University of Southern California, Department of Pharmacology and Pharmaceutical Sciences, Los Angeles, California, USA

    Jennica L. Zaro

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Zaro, J. (2015). Mylotarg: Revisiting Its Clinical Potential Post-Withdrawal. In: Wang, J., Shen, WC., Zaro, J. (eds) Antibody-Drug Conjugates. AAPS Advances in the Pharmaceutical Sciences Series, vol 17. Springer, Cham. https://doi.org/10.1007/978-3-319-13081-1_10

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