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A Review of the Current FDA-Approved Antibody-Drug Conjugates: Landmark Clinical Trials and Indications

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Abstract

Despite considerable treatment progress, cancer remains among the leading causes of death worldwide. Antibody-drug conjugates (ADCs), a rapidly growing class of systemic therapy, show promise by combining the properties of conventional chemotherapy and targeted therapy. Antibody-drug conjugates have been shown to be more efficacious than traditional chemotherapy. To date, there are 13 ADCs approved by the United States Food and Drug Administration (FDA) for treating various hematological and solid organ cancers. There are several new promising ADCs that are being developed and are in clinical trials. This review provides an overview of the current FDA-approved ADCs, the landmark clinical trials that led to their approval, the common toxicities seen in the landmark trials, the challenges associated with ADCs, and the potential future directions.

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  1. Division of Hematology-Oncology, Fred & Pamela Buffett Cancer Center, University of Nebraska Medical Center, 986840 Nebraska Medical Center, Omaha, NE, 68198-6840, USA

    Meghana Kesireddy & Samia Asif

  2. Division of Internal Medicine, Creighton University, Omaha, NE, USA

    Srikanth Reddy Kothapalli & Sai Giridhar Gundepalli

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All the authors, Meghana Kesireddy, Srikanth Reddy Kothapalli, Sai Giridhar Gundepalli, and Samia Asif, declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.

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MK: conceptualization, writing-original draft, writing- review & editing; SRK and SGG: writing- original draft; SA: writing- review& editing, supervision.

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Kesireddy, M., Kothapalli, S.R., Gundepalli, S.G. et al. A Review of the Current FDA-Approved Antibody-Drug Conjugates: Landmark Clinical Trials and Indications. Pharm Med 38, 39–54 (2024). https://doi.org/10.1007/s40290-023-00505-8

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