| アブストラクト | This study provides a detailed pharmacological evaluation of the recently approved antibody-drug conjugates (ADCs), fam-trastuzumab deruxtecan-nxki and sacituzumab govitecan-hziy, focusing on their adverse event (AE) profiles post-approval by the United States Food and Drug Administration (US FDA) for breast cancer (BC) treatment. By assessing their safety profiles, this study aims to provide clinically relevant insights into their impact and highlight the necessity for ongoing post-marketing surveillance. AE data were extracted from the US FDA's Adverse Event Reporting System (FAERS) (2019-2023), focusing on reports filed after each drug's approval, and descriptive statistical methods were used to classify and compare AE frequencies for both therapies. FAERS recorded eight AEs for fam-trastuzumab deruxtecan-nxki and thirteen for sacituzumab govitecan-hziy, despite the latter's later approval. AEs linked to fam-trastuzumab deruxtecan-nxki were musculoskeletal and infection-related, while sacituzumab govitecan-hziy showed broader systemic effects (musculoskeletal, gastrointestinal, cardiovascular, and dermatological). One patient receiving fam-trastuzumab deruxtecan-nxki experienced elevated ALT levels, suggesting potential hepatic involvement. While both therapies demonstrate therapeutic promise, continuous safety monitoring is essential. The FAERS dataset's demographic limitations highlight the need for more comprehensive post-marketing surveillance to assess long-term AE risks and optimize BC treatment safety. |
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| ジャーナル名 | Toxicology reports |
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| Pubmed追加日 | 2025/6/12 |
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| 投稿者 | Alrosan, Amjad Z; Dmour, Isra; Rataan, Aseel O; Heilat, Ghaith B; Alrosan, Khaled |
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| 組織名 | Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmaceutical;Sciences, The Hashemite University, Zarqa 13133, Jordan.;Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy,;Yarmouk University, Irbid 21163, Jordan.;Department of General Surgery and Urology, Faculty of Medicine, The Jordan;University of Science and Technology, Irbid 22110, Jordan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40502326/ |
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