Trop-2 Therapy in Metastatic Triple-Negative Breast Cancer in Italy: Clinical Opportunity and Regulatory Pitfalls

Trop-2 is an ideal candidate for targeted therapeutics because it is a transmembrane protein with an extracellular domain overexpressed in a wide variety of tumors, and is upregulated in normal cells. Consequently, several Trop-2-targeted drugs have recently been developed for clinical use, such as...

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Autores principales:	Sara Bravaccini, Roberta Maltoni
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	sacituzumab govitecan metastatic triple-negative breast cancer Trop-2 guidelines patient selection Medicine R
Acceso en línea:	https://doaj.org/article/1969c0c6d1fe4cd3bb52879c006c3111
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id	oai:doaj.org-article:1969c0c6d1fe4cd3bb52879c006c3111
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spelling	oai:doaj.org-article:1969c0c6d1fe4cd3bb52879c006c31112021-11-25T18:08:02ZTrop-2 Therapy in Metastatic Triple-Negative Breast Cancer in Italy: Clinical Opportunity and Regulatory Pitfalls10.3390/jpm111112112075-4426https://doaj.org/article/1969c0c6d1fe4cd3bb52879c006c31112021-11-01T00:00:00Zhttps://www.mdpi.com/2075-4426/11/11/1211https://doaj.org/toc/2075-4426Trop-2 is an ideal candidate for targeted therapeutics because it is a transmembrane protein with an extracellular domain overexpressed in a wide variety of tumors, and is upregulated in normal cells. Consequently, several Trop-2-targeted drugs have recently been developed for clinical use, such as anti-Trop-2 antibodies. Sacituzumab govitecan, a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, was recently approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer. In Italy, this treatment cannot be used in clinical practice because it has not yet been approved by the Agenzia Italiana del Farmaco (AIFA, Rome, Italy). In Italy, this is not a new problem, in fact, when a new compound is approved by the U.S. and Europe, there is often a delay in its approval for use. The adoption of universal guidelines and the standardization of Trop-2 evaluation is urgently needed.Sara BravacciniRoberta MaltoniMDPI AGarticlesacituzumab govitecanmetastatic triple-negative breast cancerTrop-2guidelinespatient selectionMedicineRENJournal of Personalized Medicine, Vol 11, Iss 1211, p 1211 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	sacituzumab govitecan metastatic triple-negative breast cancer Trop-2 guidelines patient selection Medicine R
spellingShingle	sacituzumab govitecan metastatic triple-negative breast cancer Trop-2 guidelines patient selection Medicine R Sara Bravaccini Roberta Maltoni Trop-2 Therapy in Metastatic Triple-Negative Breast Cancer in Italy: Clinical Opportunity and Regulatory Pitfalls
description	Trop-2 is an ideal candidate for targeted therapeutics because it is a transmembrane protein with an extracellular domain overexpressed in a wide variety of tumors, and is upregulated in normal cells. Consequently, several Trop-2-targeted drugs have recently been developed for clinical use, such as anti-Trop-2 antibodies. Sacituzumab govitecan, a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate, was recently approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer. In Italy, this treatment cannot be used in clinical practice because it has not yet been approved by the Agenzia Italiana del Farmaco (AIFA, Rome, Italy). In Italy, this is not a new problem, in fact, when a new compound is approved by the U.S. and Europe, there is often a delay in its approval for use. The adoption of universal guidelines and the standardization of Trop-2 evaluation is urgently needed.
format	article
author	Sara Bravaccini Roberta Maltoni
author_facet	Sara Bravaccini Roberta Maltoni
author_sort	Sara Bravaccini
title	Trop-2 Therapy in Metastatic Triple-Negative Breast Cancer in Italy: Clinical Opportunity and Regulatory Pitfalls
title_short	Trop-2 Therapy in Metastatic Triple-Negative Breast Cancer in Italy: Clinical Opportunity and Regulatory Pitfalls
title_full	Trop-2 Therapy in Metastatic Triple-Negative Breast Cancer in Italy: Clinical Opportunity and Regulatory Pitfalls
title_fullStr	Trop-2 Therapy in Metastatic Triple-Negative Breast Cancer in Italy: Clinical Opportunity and Regulatory Pitfalls
title_full_unstemmed	Trop-2 Therapy in Metastatic Triple-Negative Breast Cancer in Italy: Clinical Opportunity and Regulatory Pitfalls
title_sort	trop-2 therapy in metastatic triple-negative breast cancer in italy: clinical opportunity and regulatory pitfalls
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/1969c0c6d1fe4cd3bb52879c006c3111
work_keys_str_mv	AT sarabravaccini trop2therapyinmetastatictriplenegativebreastcancerinitalyclinicalopportunityandregulatorypitfalls AT robertamaltoni trop2therapyinmetastatictriplenegativebreastcancerinitalyclinicalopportunityandregulatorypitfalls
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Trop-2 Therapy in Metastatic Triple-Negative Breast Cancer in Italy: Clinical Opportunity and Regulatory Pitfalls

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