{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T03:26:59Z","timestamp":1763695619764,"version":"3.45.0"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs - Real World Outcomes"],"published-print":{"date-parts":[[2025,12]]},"DOI":"10.1007\/s40801-025-00524-8","type":"journal-article","created":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T07:15:48Z","timestamp":1761981348000},"page":"541-550","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-World Evaluation of Regulatory Judgments on Anticancer Drug Use During Pregnancy in Japan: A Retrospective Analysis from 2004 to 2024"],"prefix":"10.1007","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3500-9921","authenticated-orcid":false,"given":"Hitoshi","family":"Kanno","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kotone","family":"Matsuyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,11,1]]},"reference":[{"key":"524_CR1","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Nonclinical Evaluation for Anticancer Pharmaceuticals S9. Tokyo: Pharmaceuticals and Medical Devices Agency (PMDA); 2009. https:\/\/www.pmda.go.jp\/files\/000156321.pdf."},{"key":"524_CR2","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals S9 Q&A. Tokyo: Pharmaceuticals and Medical Devices Agency (PMDA); 2018. https:\/\/www.pmda.go.jp\/files\/000231392.pdf."},{"key":"524_CR3","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Detection of Toxicity to Reproduction for Human Pharmaceuticals S5(R3). Tokyo: Pharmaceuticals and Medical Devices Agency (PMDA); 2020. https:\/\/www.pmda.go.jp\/files\/000156671.pdf."},{"key":"524_CR4","doi-asserted-by":"publisher","first-page":"68","DOI":"10.1016\/j.lungcan.2021.09.001","volume":"161","author":"AS Boudy","year":"2021","unstructured":"Boudy AS, Grausz N, Selleret L, et al. Use of tyrosine kinase inhibitors during pregnancy for oncogenic-driven advanced non-small cell lung carcinoma. Lung Cancer. 2021;161:68\u201375. https:\/\/doi.org\/10.1016\/j.lungcan.2021.09.001.","journal-title":"Lung Cancer"},{"issue":"18","key":"524_CR5","doi-asserted-by":"publisher","first-page":"1975","DOI":"10.1080\/14656566.2023.2293167","volume":"24","author":"D Favero","year":"2023","unstructured":"Favero D, Lapuchesky LS, Poggio F, et al. Choosing the appropriate pharmacotherapy for breast cancer during pregnancy: what needs to be considered? Expert Opin Pharmacother. 2023;24(18):1975\u201384. https:\/\/doi.org\/10.1080\/14656566.2023.2293167.","journal-title":"Expert Opin Pharmacother"},{"key":"524_CR6","unstructured":"Pharmaceuticals and Medical Devices Agency (PMDA). Darzalex Intravenous Infusion 100 mg, 400 mg (Daratumumab [Genetical Recombination]) Review Report. Tokyo: PMDA; 2017 Aug 30. https:\/\/www.pmda.go.jp\/files\/000234203.pdf"},{"key":"524_CR7","unstructured":"Pharmaceuticals and Medical Devices Agency (PMDA). Keytruda (pembrolizumab [genetical recombination]) Review Report. Tokyo: PMDA; 2017 Sep 22. Japanese. https:\/\/www.pmda.go.jp\/files\/000226881.pdf."},{"issue":"233","key":"524_CR8","first-page":"72064","volume":"79","author":"US Food and Drug Administration","year":"2014","unstructured":"US Food and Drug Administration. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling\u2014final rule. Fed Regist. 2014;79(233):72064\u2013103.","journal-title":"Fed Regist"},{"key":"524_CR9","unstructured":"Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical Evaluation Division. Guidance on the format of package inserts for prescription drugs. Tokyo: MHLW; 2020. Japanese. https:\/\/www.pmda.go.jp\/files\/000218446.pdf."},{"key":"524_CR10","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2024.108727","volume":"130","author":"P Barrow","year":"2024","unstructured":"Barrow P. Review of embryo-fetal developmental toxicity studies performed for pharmaceuticals approved by FDA in 2022 and 2023. Reprod Toxicol. 2024;130:108727. https:\/\/doi.org\/10.1016\/j.reprotox.2024.108727.","journal-title":"Reprod Toxicol"},{"key":"524_CR11","doi-asserted-by":"publisher","first-page":"100","DOI":"10.1016\/j.reprotox.2022.06.012","volume":"112","author":"P Barrow","year":"2022","unstructured":"Barrow P. Review of embryo-fetal developmental toxicity studies performed for pharmaceuticals approved by FDA in 2020 and 2021. Reprod Toxicol. 2022;112:100\u20138. https:\/\/doi.org\/10.1016\/j.reprotox.2022.06.012.","journal-title":"Reprod Toxicol"},{"issue":"6","key":"524_CR12","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.13180","volume":"4","author":"M van Gerwen","year":"2021","unstructured":"van Gerwen M, Maggen C, Cardonick E, et al. Association of chemotherapy timing in pregnancy with congenital malformation. JAMA Netw Open. 2021;4(6):e2113180. https:\/\/doi.org\/10.1001\/jamanetworkopen.2021.13180.","journal-title":"JAMA Netw Open"},{"issue":"2","key":"524_CR13","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1136\/ijgc-2018-000061","volume":"29","author":"C Maggen","year":"2019","unstructured":"Maggen C, van Gerwen M, Van Calsteren K, et al. Management of cancer during pregnancy and current evidence of obstetric, neonatal and pediatric outcome: a review article. Int J Gynecol Cancer. 2019;29(2):404\u201316. https:\/\/doi.org\/10.1136\/ijgc-2018-000061.","journal-title":"Int J Gynecol Cancer"},{"issue":"13","key":"524_CR14","doi-asserted-by":"publisher","DOI":"10.3390\/cancers14133103","volume":"14","author":"S Triarico","year":"2022","unstructured":"Triarico S, Rivetti S, Capozza MA, et al. Transplacental passage and fetal effects of antineoplastic treatment during pregnancy. Cancers (Basel). 2022;14(13):3103. https:\/\/doi.org\/10.3390\/cancers14133103.","journal-title":"Cancers (Basel)"},{"issue":"8","key":"524_CR15","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.15094","volume":"3","author":"JJ Byrne","year":"2020","unstructured":"Byrne JJ, Saucedo AM, Spong CY. Evaluation of drug labels following the 2015 pregnancy and lactation labeling rule. JAMA Netw Open. 2020;3(8):e2015094. https:\/\/doi.org\/10.1001\/jamanetworkopen.2020.15094.","journal-title":"JAMA Netw Open"}],"container-title":["Drugs - Real World Outcomes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40801-025-00524-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40801-025-00524-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40801-025-00524-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T01:17:05Z","timestamp":1763687825000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40801-025-00524-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,1]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["524"],"URL":"https:\/\/doi.org\/10.1007\/s40801-025-00524-8","relation":{},"ISSN":["2199-1154","2198-9788"],"issn-type":[{"type":"print","value":"2199-1154"},{"type":"electronic","value":"2198-9788"}],"subject":[],"published":{"date-parts":[[2025,11,1]]},"assertion":[{"value":"5 October 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 November 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare that they have no financial or non-financial competing interests, including personal, professional, or institutional relationships, that could be perceived as influencing the work reported in this manuscript.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All data used in this study were obtained from publicly available regulatory documents issued by the PMDA and FDA. While summary findings are presented in the manuscript, detailed drug-level data including structural classification, regulatory judgments (PMDA and FDA), and reproductive toxicity findings are provided in Supplementary Table 1 (see ESM), enabling independent verification of the study results. The analysis can be independently verified by consulting the same public regulatory sources.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"HK contributed substantially to the conception and design of the study, performed the research, and analyzed the data. KM contributed to the drafting and critical revision of the manuscript, verified the coding results for classification consistency, and also participated in data analysis. Both authors approved the final version of the manuscript and agree to be accountable for all aspects of the work in ensuring its accuracy and integrity.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}