Sacituzumab govitecan, sold under the brand name Trodelvy, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate used for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer.
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Sacituzumab govitecan has a boxed warning about the risk of severe neutropenia and severe diarrhea.
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Sacituzumab govitecan was approved for medical use in the European Union in November 2021.
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Sacituzumab govitecan is given in a 21-day treatment cycle in which an injection is only given a few days of the cycle.
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Sacituzumab govitecan is a conjugate of the humanized anti-Trop-2 monoclonal antibody linked with SN-38, the active metabolite of irinotecan.
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Sacituzumab govitecan is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, meaning that the drug targets the Trop-2 receptor that helps the cancer grow, divide and spread, and is linked to topoisomerase inhibitor, which is a chemical compound that is toxic to cancer cells.
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In February 2016, Immunomedics announced that sacituzumab govitecan had received an FDA breakthrough therapy designation for the treatment of people with triple-negative breast cancer who have failed at least two other prior therapies for metastatic disease.
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Sacituzumab govitecan was added to the proposed International nonproprietary name list in 2015, and to the recommended list in 2016.
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Sacituzumab govitecan-hziy was approved for medical use in the United States in April 2020.
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Sacituzumab govitecan-hziy was granted accelerated approval along with priority review, breakthrough therapy, and fast track designations.
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Sacituzumab govitecan was approved for medical use in the European Union in November 2021.
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