{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T04:59:26Z","timestamp":1790312366264,"version":"4.1.0"},"reference-count":23,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T00:00:00Z","timestamp":1790121600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Clin. Med.","JCM"],"abstract":"<jats:p>Background: Sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) are TROP2-directed antibody\u2013drug conjugates with topoisomerase I inhibitor payloads but distinct recognized adverse-event profiles. Comparative reporting patterns for these agents remain incompletely characterized. Methods: We analyzed a case-level line listing downloaded from the U.S. Food and Drug Administration (FDA) Adverse Event Monitoring System (AEMS; formerly the FDA Adverse Event Reporting System [FAERS]) Public Dashboard on 7 July 2026. Reports listing SG or Dato-DXd among suspect product names or active ingredients were assigned mutually exclusively. Prespecified toxicity phenotypes and individual MedDRA Preferred Terms (PTs) were compared using reporting proportions, comparative reporting odds ratios (RORs), false-discovery-rate correction, and multivariable logistic regression. A breast cancer-restricted analysis with crude RORs and 95% CIs was also performed. Results: The cohort comprised 6368 distinct Case IDs (SG, 5714; Dato-DXd, 654). Compared with SG, Dato-DXd reports were enriched for mucositis\/stomatitis (18.3% vs. 1.3%; ROR, 17.61; adjusted reporting odds ratio [aROR], 20.04) and ocular toxicity (10.9% vs. 0.9%; ROR, 13.26; aROR, 13.98). The aRORs for Dato-DXd versus SG were 0.11 for hematologic cytopenia, 0.12 for neutropenia\/febrile neutropenia, 0.11 for diarrhea\/colitis, and 0.57 for infection\/sepsis. Exact interstitial lung disease\/pneumonitis showed reporting enrichment with Dato-DXd in the unadjusted analysis (ROR, 3.12), but the comparative reporting association was attenuated after adjustment (aROR, 1.44; 95% CI, 0.87\u20132.39). Overall gastrointestinal reporting was similar, and the breast cancer-restricted crude RORs were directionally consistent with the full-cohort comparisons. Conclusions: SG and Dato-DXd showed distinct adverse-event reporting profiles. SG reports were characterized by relative enrichment of hematologic and diarrheal events, whereas Dato-DXd reports were enriched for mucosal and ocular events. These findings are hypothesis-generating reporting comparisons and should not be interpreted as incidence estimates, causal associations, or conventional head-to-head safety estimates.<\/jats:p>","DOI":"10.3390\/jcm15197405","type":"journal-article","created":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T16:10:31Z","timestamp":1790179831000},"page":"7405","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative Safety Profiles of Sacituzumab Govitecan and Datopotamab Deruxtecan: A Real-World Pharmacovigilance Study"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7858-8180","authenticated-orcid":false,"given":"Ziya","family":"Kalkan","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Faculty of Medicine, Dicle University, Diyarbak\u0131r 21280, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7854-097X","authenticated-orcid":false,"given":"Murat","family":"Bardakci","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Gazi Ya\u015fargil Training and Research Hospital, Diyarbak\u0131r 21010, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5971-998X","authenticated-orcid":false,"given":"Tugba","family":"Tezer Kalkan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Gazi Ya\u015fargil Training and Research Hospital, Diyarbak\u0131r 21010, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4784-6743","authenticated-orcid":false,"given":"Yakup","family":"Ergun","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Bower Hospital, Diyarbak\u0131r 21100, T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e254","DOI":"10.1016\/S1470-2045(16)30030-4","article-title":"Antibody-drug conjugates for cancer therapy","volume":"17","author":"Thomas","year":"2016","journal-title":"Lancet Oncol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"108296","DOI":"10.1016\/j.pharmthera.2022.108296","article-title":"Advances in Trop2-targeted therapy: Novel agents and opportunities beyond breast cancer","volume":"239","author":"Liu","year":"2022","journal-title":"Pharmacol. Ther."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1038\/s41571-021-00470-8","article-title":"Unlocking the potential of antibody-drug conjugates for cancer therapy","volume":"18","author":"Drago","year":"2021","journal-title":"Nat. Rev. Clin. Oncol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1390","DOI":"10.1158\/1078-0432.CCR-24-1525","article-title":"The Mode of Action and Clinical Outcomes of Sacituzumab Govitecan in Solid Tumors","volume":"31","author":"Tolaney","year":"2025","journal-title":"Clin. Cancer Res."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"2329","DOI":"10.1158\/1535-7163.MCT-21-0206","article-title":"Datopotamab Deruxtecan, a Novel TROP2-directed Antibody-drug Conjugate, Demonstrates Potent Antitumor Activity by Efficient Drug Delivery to Tumor Cells","volume":"20","author":"Okajima","year":"2021","journal-title":"Mol. Cancer Ther."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"1912","DOI":"10.1056\/NEJMoa2511734","article-title":"ASCENT-03 Clinical Trial Investigators. Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer","volume":"393","author":"Punie","year":"2025","journal-title":"N. Engl. J. Med."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1066","DOI":"10.1016\/j.annonc.2026.03.008","article-title":"TROPION-Breast02 investigators. Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): A randomised, open-label, international, phase III trial","volume":"37","author":"Dent","year":"2026","journal-title":"Ann. Oncol."},{"key":"ref_8","unstructured":"U.S. Food and Drug Administration (2026, September 13). New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS), Available online: https:\/\/www.fda.gov\/drugs\/fda-adverse-event-monitoring-system-aems\/new-safety-information-or-potential-signals-serious-risks-identified-fda-adverse-event-monitoring."},{"key":"ref_9","unstructured":"U.S. Food and Drug Administration (2026, September 13). FDA Adverse Event Monitoring System (AEMS) Public Dashboard, Available online: https:\/\/www.fda.gov\/drugs\/fda-adverse-event-monitoring-system-aems\/fda-adverse-event-monitoring-system-aems-public-dashboard."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1177\/2042098616685010","article-title":"The impact of database restriction on pharmacovigilance signal detection of selected cancer therapies","volume":"8","author":"Hauben","year":"2017","journal-title":"Ther. Adv. Drug Saf."},{"key":"ref_11","unstructured":"U.S. Food and Drug Administration (2026, July 12). Data Mining at FDA\u2014White Paper, Available online: https:\/\/fda.gov\/science-research\/data-mining\/data-mining-fda-white-paper."},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Liu, W., Du, Q., Guo, Z., Ye, X., and Liu, J. (2023). Post-marketing safety surveillance of sacituzumab govitecan: An observational, pharmacovigilance study leveraging FAERS database. Front. Pharmacol., 14.","DOI":"10.3389\/fphar.2023.1283247"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"102720","DOI":"10.1016\/j.ctrv.2024.102720","article-title":"Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan","volume":"125","author":"Heist","year":"2024","journal-title":"Cancer Treat. Rev."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"435","DOI":"10.1007\/s11523-024-01058-9","article-title":"Emerging Toxicities of Antibody-Drug Conjugates for Breast Cancer: Clinical Prioritization of Adverse Events from the FDA Adverse Event Reporting System","volume":"19","author":"Cecco","year":"2024","journal-title":"Target. Oncol."},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"Gui, X., Zhao, J., Ding, L., Chai, J., Lai, H., Cai, Y., Luo, S., Zeng, Y., Wu, W., and Chen, H. (2023). Assessing real-world safety concerns of Sacituzumab govitecan: A disproportionality analysis using spontaneous reports in the FDA adverse event reporting system. Front. Oncol., 13.","DOI":"10.3389\/fonc.2023.1276976"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1529","DOI":"10.1056\/NEJMoa2028485","article-title":"ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer","volume":"384","author":"Bardia","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_17","unstructured":"U.S. Food and Drug Administration (2025). Trodelvy (Sacituzumab Govitecan-Hziy) for Injection, for Intravenous Use: Prescribing Information."},{"key":"ref_18","unstructured":"U.S. Food and Drug Administration (2026). Datroway (Datopotamab Deruxtecan-Dlnk) for Injection, for Intravenous Use: Prescribing Information."},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Cutroneo, P.M., Sartori, D., Tuccori, M., Crisafulli, S., Battini, V., Carnovale, C., Rafaniello, C., Capuano, A., Poluzzi, E., and Moretti, U. (2024). Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems. Front. Drug Saf. Regul., 3.","DOI":"10.3389\/fdsfr.2023.1323057"},{"key":"ref_20","unstructured":"Daiichi Sankyo, Inc. (2026, July 17). AstraZeneca Pharmaceuticals LP. DATROWAY (Datopotamab Deruxtecan-Dlnk) for Injection, for Intravenous Use: Full Prescribing Information, Available online: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2025\/761394s000lbl.pdf."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"117863","DOI":"10.1016\/j.ejmech.2025.117863","article-title":"Evolution of TROP2: Biological insights and clinical applications","volume":"296","author":"Zhang","year":"2025","journal-title":"Eur. J. Med. Chem."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"22496","DOI":"10.18632\/oncotarget.4318","article-title":"Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC)","volume":"6","author":"Goldenberg","year":"2015","journal-title":"Oncotarget"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"701","DOI":"10.1369\/0022155411410430","article-title":"Expression of Trop2 cell surface glycoprotein in normal and tumor tissues: Potential implications as a cancer therapeutic target","volume":"59","author":"Stepan","year":"2011","journal-title":"J. Histochem. Cytochem."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/19\/7405\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T04:17:28Z","timestamp":1790309848000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/15\/19\/7405"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,23]]},"references-count":23,"journal-issue":{"issue":"19","published-online":{"date-parts":[[2026,10]]}},"alternative-id":["jcm15197405"],"URL":"https:\/\/doi.org\/10.3390\/jcm15197405","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,23]]}}}