{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T08:07:40Z","timestamp":1789373260213,"version":"build-2803163510"},"reference-count":39,"publisher":"XMLink","license":[{"start":{"date-parts":[[2027,1,1]],"date-time":"2027-01-01T00:00:00Z","timestamp":1798761600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ejgo.org"],"crossmark-restriction":false},"short-container-title":["J Gynecol Oncol"],"DOI":"10.3802\/jgo.2027.38.e27","type":"journal-article","created":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T07:48:07Z","timestamp":1789372087000},"update-policy":"https:\/\/doi.org\/10.3802\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Post-marketing safety assessment of mirvetuximab soravtansine: a disproportionality analysis based on the FDA Adverse Event Reporting System"],"prefix":"10.3802","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-0754-3373","authenticated-orcid":false,"given":"Haowen","family":"Tan","sequence":"first","affiliation":[{"name":"Office of Good Clinical Practice, Wuzhou Red Cross Hospital, Wuzhou, China."},{"name":"Department of Pharmacy, Wuzhou Red Cross Hospital, Wuzhou, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-6812-0214","authenticated-orcid":false,"given":"Xuan","family":"Ou","sequence":"additional","affiliation":[{"name":"Office of Good Clinical Practice, Wuzhou Red Cross Hospital, Wuzhou, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4641-2874","authenticated-orcid":false,"given":"Luping","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Wuzhou Red Cross Hospital, Wuzhou, China."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8695-8083","authenticated-orcid":false,"given":"Ying","family":"Chen","sequence":"additional","affiliation":[{"name":"Office of Good Clinical Practice, Wuzhou Red Cross Hospital, Wuzhou, China."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"18617","published-online":{"date-parts":[[2027]]},"reference":[{"key":"10.3802\/jgo.2027.38.e27_ref1","first-page":"12","volume":"74","author":"Siegel","year":"2024","journal-title":"CA Cancer J Clin"},{"key":"10.3802\/jgo.2027.38.e27_ref2","first-page":"229","volume":"74","author":"Bray","year":"2024","journal-title":"CA Cancer J Clin"},{"key":"10.3802\/jgo.2027.38.e27_ref3","doi-asserted-by":"crossref","first-page":"2436","DOI":"10.1200\/JCO.22.01900","volume":"41","author":"Matulonis","year":"2023","journal-title":"J Clin Oncol"},{"key":"10.3802\/jgo.2027.38.e27_ref4","doi-asserted-by":"crossref","first-page":"964","DOI":"10.1136\/ijgc-2024-005457","volume":"34","author":"Silva","year":"2024","journal-title":"Int J Gynecol Cancer"},{"key":"10.3802\/jgo.2027.38.e27_ref5","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1038\/s41571-020-0339-5","volume":"17","author":"Scaranti","year":"2020","journal-title":"Nat Rev Clin Oncol"},{"key":"10.3802\/jgo.2027.38.e27_ref6","doi-asserted-by":"crossref","first-page":"1605","DOI":"10.1158\/1535-7163.MCT-14-1095","volume":"14","author":"Ab","year":"2015","journal-title":"Mol Cancer Ther"},{"key":"10.3802\/jgo.2027.38.e27_ref7","doi-asserted-by":"crossref","first-page":"1703","DOI":"10.1021\/acs.molpharmaceut.5b00175","volume":"12","author":"Hong","year":"2015","journal-title":"Mol Pharm"},{"key":"10.3802\/jgo.2027.38.e27_ref8","doi-asserted-by":"crossref","first-page":"3214","DOI":"10.1158\/0008-5472.CAN-05-3973","volume":"66","author":"Kovtun","year":"2006","journal-title":"Cancer Res"},{"key":"10.3802\/jgo.2027.38.e27_ref9","unstructured":"Food and Drug Administration (FDA). FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FR\u03b1 positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer. Silver Spring, MD. FDA. 2022. cited 2026 Mar 3. Available from: . https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant"},{"key":"10.3802\/jgo.2027.38.e27_ref10","doi-asserted-by":"crossref","first-page":"3080","DOI":"10.1002\/cncr.30736","volume":"123","author":"Moore","year":"2017","journal-title":"Cancer"},{"key":"10.3802\/jgo.2027.38.e27_ref11","doi-asserted-by":"crossref","first-page":"757","DOI":"10.1016\/j.annonc.2021.02.017","volume":"32","author":"Moore","year":"2021","journal-title":"Ann Oncol"},{"key":"10.3802\/jgo.2027.38.e27_ref12","doi-asserted-by":"crossref","first-page":"2162","DOI":"10.1056\/NEJMoa2309169","volume":"389","author":"Moore","year":"2023","journal-title":"N Engl J Med"},{"key":"10.3802\/jgo.2027.38.e27_ref13","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1016\/j.ygyno.2024.10.013","volume":"191","author":"Moore","year":"2024","journal-title":"Gynecol Oncol"},{"key":"10.3802\/jgo.2027.38.e27_ref14","unstructured":"International Council for Harmonisation (ICH). Pharmacovigilance Planning E2E. Geneva. ICH. c2026. cited 2026 Mar 3. Available from: . https:\/\/www.ich.org\/page\/efficacy-guidelines"},{"key":"10.3802\/jgo.2027.38.e27_ref15","unstructured":"European Medicines Agency. Guideline on good pharmacovigilance practices. Amsterdam. European Medicines Agency. 2017. cited 2026 Mar 3. Available from: . https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf"},{"key":"10.3802\/jgo.2027.38.e27_ref16","doi-asserted-by":"crossref","first-page":"4094","DOI":"10.1097\/JS9.0000000000002435","volume":"111","author":"Duan","year":"2025","journal-title":"Int J Surg"},{"key":"10.3802\/jgo.2027.38.e27_ref17","doi-asserted-by":"crossref","first-page":"1397692","DOI":"10.3389\/fimmu.2024.1397692","volume":"15","author":"Yu","year":"2024","journal-title":"Front Immunol"},{"key":"10.3802\/jgo.2027.38.e27_ref18","doi-asserted-by":"crossref","first-page":"256","DOI":"10.1002\/cpt.3098","volume":"115","author":"Li","year":"2024","journal-title":"Clin Pharmacol Ther"},{"key":"10.3802\/jgo.2027.38.e27_ref19","doi-asserted-by":"crossref","first-page":"1405023","DOI":"10.3389\/fphar.2024.1405023","volume":"15","author":"Liu","year":"2024","journal-title":"Front Pharmacol"},{"key":"10.3802\/jgo.2027.38.e27_ref20","doi-asserted-by":"crossref","first-page":"565","DOI":"10.1080\/14740338.2024.2438748","volume":"24","author":"Chen","year":"2025","journal-title":"Expert Opin Drug Saf"},{"key":"10.3802\/jgo.2027.38.e27_ref21","doi-asserted-by":"crossref","first-page":"519","DOI":"10.1002\/pds.1001","volume":"13","author":"Rothman","year":"2004","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.3802\/jgo.2027.38.e27_ref22","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1002\/pds.677","volume":"10","author":"Evans","year":"2001","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.3802\/jgo.2027.38.e27_ref23","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1007\/s002280050466","volume":"54","author":"Bate","year":"1998","journal-title":"Eur J Clin Pharmacol"},{"key":"10.3802\/jgo.2027.38.e27_ref24","first-page":"190","volume":"53","author":"O\u2019Neill","year":"1999","journal-title":"Am Stat"},{"key":"10.3802\/jgo.2027.38.e27_ref25","doi-asserted-by":"crossref","first-page":"881","DOI":"10.1007\/s40264-023-01334-z","volume":"46","author":"Shu","year":"2023","journal-title":"Drug Saf"},{"key":"10.3802\/jgo.2027.38.e27_ref26","unstructured":"European Medicines Agency. EudraVigilance System Overview. Important medical event terms list (MedDRA version 28.0). Amsterdam. European Medicines Agency. c2026. cited 2026 Mar 3. Available from: . https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/pharmacovigilance-research-development\/eudravigilance\/eudravigilance-system-overview"},{"key":"10.3802\/jgo.2027.38.e27_ref27","unstructured":"European Medicines Agency. Signal Management. Designated medical event list. Amsterdam. European Medicines Agency. c2026. cited 2026 Mar 3. Available from: . https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/pharmacovigilance-post-authorisation\/signal-management#designated-medical-events-10341"},{"key":"10.3802\/jgo.2027.38.e27_ref28","doi-asserted-by":"crossref","first-page":"435","DOI":"10.1007\/s11523-024-01058-9","volume":"19","author":"Cecco","year":"2024","journal-title":"Target Oncol"},{"key":"10.3802\/jgo.2027.38.e27_ref29","doi-asserted-by":"crossref","first-page":"599","DOI":"10.2165\/11599740-000000000-00000","volume":"35","author":"Cornelius","year":"2012","journal-title":"Drug Saf"},{"key":"10.3802\/jgo.2027.38.e27_ref30","doi-asserted-by":"crossref","first-page":"995","DOI":"10.1007\/s40264-013-0061-7","volume":"36","author":"Sauzet","year":"2013","journal-title":"Drug Saf"},{"key":"10.3802\/jgo.2027.38.e27_ref31","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1111\/jcpt.13024","volume":"45","author":"Kinoshita","year":"2020","journal-title":"J Clin Pharm Ther"},{"key":"10.3802\/jgo.2027.38.e27_ref32","doi-asserted-by":"crossref","first-page":"1727","DOI":"10.1158\/1078-0432.CCR-18-2474","volume":"25","author":"Matulonis","year":"2019","journal-title":"Clin Cancer Res"},{"key":"10.3802\/jgo.2027.38.e27_ref33","doi-asserted-by":"crossref","first-page":"792","DOI":"10.1097\/ICO.0000000000002934","volume":"41","author":"Canestraro","year":"2022","journal-title":"Cornea"},{"key":"10.3802\/jgo.2027.38.e27_ref34","unstructured":"ImmunoGen. Elahere\u00ae (mirvetuximab soravtansine-gynx) injection, for intravenous use. Silver Spring, MD. FDA. 2022. cited 2026 Mar 3. Available from: . https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/761310Origs005lbl.pdf"},{"key":"10.3802\/jgo.2027.38.e27_ref35","doi-asserted-by":"crossref","first-page":"1196","DOI":"10.1016\/j.ophtha.2017.03.041","volume":"124","author":"Daniel","year":"2017","journal-title":"Ophthalmology"},{"key":"10.3802\/jgo.2027.38.e27_ref36","unstructured":"ClinicalTrials.gov. A study of mirvetuximab soravtansine in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression (SORAYA) (NCT04296890). Waltham, MA. ImmunoGen, Inc. 2024. cited 2026 Apr 9. Available from: . https:\/\/clinicaltrials.gov\/study\/NCT04296890"},{"key":"10.3802\/jgo.2027.38.e27_ref37","unstructured":"ClinicalTrials.gov. First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of mirvetuximab soravtansine in adults with ovarian cancer and other folate receptor 1 (FOLR1)-positive solid tumors (IMGN853-0401) (NCT01609556). Waltham, MA. ImmunoGen, Inc. 2021. cited 2026 Apr 9. Available from: . https:\/\/clinicaltrials.gov\/study\/NCT01609556"},{"key":"10.3802\/jgo.2027.38.e27_ref38","doi-asserted-by":"crossref","first-page":"101738","DOI":"10.1016\/j.gore.2025.101738","volume":"59","author":"Lang","year":"2025","journal-title":"Gynecol Oncol Rep"},{"key":"10.3802\/jgo.2027.38.e27_ref39","doi-asserted-by":"crossref","first-page":"101486","DOI":"10.1016\/j.gore.2024.101486","volume":"55","author":"Clark","year":"2024","journal-title":"Gynecol Oncol Rep"}],"container-title":["Journal of Gynecologic Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ejgo.org\/pdf\/10.3802\/jgo.2027.38.e27","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ejgo.org\/DOIx.php?id=10.3802\/jgo.2027.38.e27","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ejgo.org\/DOIx.php?id=10.3802\/jgo.2027.38.e27","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T07:49:15Z","timestamp":1789372155000},"score":1,"resource":{"primary":{"URL":"https:\/\/ejgo.org\/DOIx.php?id=10.3802\/jgo.2027.38.e27"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2027]]},"references-count":39,"URL":"https:\/\/doi.org\/10.3802\/jgo.2027.38.e27","relation":{},"ISSN":["2005-0380","2005-0399"],"issn-type":[{"value":"2005-0380","type":"print"},{"value":"2005-0399","type":"electronic"}],"subject":[],"published":{"date-parts":[[2027]]},"assertion":[{"value":"2026-03-12","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-21","name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-13","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-03","name":"published_online","label":"Published online","group":{"name":"publication_history","label":"Publication History"}},{"value":"\u00a9 2027. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology","name":"copyright","label":"Copyright","group":{"name":"Copyright_and_licensing","label":"Copyright and Licensing"}},{"value":"This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.","name":"license","label":"License","explanation":{"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},"group":{"name":"Copyright_and_licensing","label":"Copyright and Licensing"}}],"article-number":"e27"}}