{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,4]],"date-time":"2026-07-04T06:15:09Z","timestamp":1783145709803,"version":"3.54.6"},"reference-count":27,"publisher":"Japanese Society for Lymphoreticular Tissue Research","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCEH","J Clin Exp Hematopathol"],"published-print":{"date-parts":[[2026]]},"DOI":"10.3960\/jslrt.25054","type":"journal-article","created":{"date-parts":[[2026,3,15]],"date-time":"2026-03-15T22:10:06Z","timestamp":1773612606000},"page":"111-121","source":"Crossref","is-referenced-by-count":0,"title":["Post-marketing surveillance of tirabrutinib for Waldenstr\u00f6m\u2019s macroglobulinemia\/lymphoplasmacytic lymphoma in Japan"],"prefix":"10.3960","volume":"66","author":[{"given":"Akira","family":"Kawasaki","sequence":"first","affiliation":[{"name":"Department of Pharmacovigilance, Ono Pharmaceutical Co., Ltd., Osaka, Japan,"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshikazu","family":"Nagano","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance, Ono Pharmaceutical Co., Ltd., Osaka, Japan,"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yudai","family":"Higuchi","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs, Ono Pharmaceutical Co., Ltd., Osaka, Japan,"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryo","family":"Nishikawa","sequence":"additional","affiliation":[{"name":"Department of Neuro-Oncology\/Neurosurgery, Saitama Medical University International Medical Center, Saitama, Japan,"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[{"name":"Department of Hematology, National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2349","reference":[{"key":"1","doi-asserted-by":"crossref","unstructured":"1 Ju\u00e1rez-Salcedo LM, Castillo JJ. Lymphoplasmacytic lymphoma and marginal zone lymphoma. Hematol Oncol Clin North Am. 2019; 33: 639-656.","DOI":"10.1016\/j.hoc.2019.03.004"},{"key":"2","doi-asserted-by":"crossref","unstructured":"2 Vijay A, Gertz MA. Waldenstr\u00f6m macroglobulinemia. Blood. 2007; 109: 5096-5103.","DOI":"10.1182\/blood-2006-11-055012"},{"key":"3","doi-asserted-by":"crossref","unstructured":"3 Owen RG, Treon SP, Al-Katib A <i>et al.<\/i> Clinicopathological definition of Waldenstrom\u2019s macroglobulinemia: consensus panel recommendations from the Second International Workshop on Waldenstrom\u2019s Macroglobulinemia. Semin Oncol. 2003; 30: 110-115.","DOI":"10.1053\/sonc.2003.50082"},{"key":"4","unstructured":"4 Sekiguchi N. [Waldenstr\u00f6m macroglobulinemia: Japanese perception] [in Japanese]. Rinsho Ketsueki. 2019; 60: 988-997."},{"key":"5","doi-asserted-by":"crossref","unstructured":"5 Buske C, Jurczak W, Salem JE, Dimopoulos MA. Managing Waldenstr\u00f6m\u2019s macroglobulinemia with BTK inhibitors. Leukemia. 2023; 37: 35-46.","DOI":"10.1038\/s41375-022-01732-9"},{"key":"6","unstructured":"6 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines<sup>\u00ae<\/sup>) for Waldenstr\u00f6m Macroglobulinemia\/Lymphoplasmacytic Lymphoma V.1.2026. \u00a9National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed December 10, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way."},{"key":"7","unstructured":"7 The Japanese Society of Hematology. [Guidelines for hematological malignancies, 3.1 Edition (2024)] [in Japanese]. http:\/\/www.jshem.or.jp\/gui-hemali\/table.html. Accessed March 11, 2025."},{"key":"8","doi-asserted-by":"crossref","unstructured":"8 Pal Singh S, Dammeijer F, Hendriks RW. Role of Bruton\u2019s tyrosine kinase in B cells and malignancies. Mol Cancer. 2018; 17: 57.","DOI":"10.1186\/s12943-018-0779-z"},{"key":"9","doi-asserted-by":"crossref","unstructured":"9 Liclican A, Serafini L, Xing W <i>et al.<\/i> Biochemical characterization of tirabrutinib and other irreversible inhibitors of Bruton\u2019s tyrosine kinase reveals differences in on - and off - target inhibition. Biochim Biophys Acta Gen Subj. 2020; 1864: 129531.","DOI":"10.1016\/j.bbagen.2020.129531"},{"key":"10","doi-asserted-by":"crossref","unstructured":"10 Kozaki R, Yasuhiro T, Kato H <i>et al.<\/i> Investigation of the anti-tumor mechanism of tirabrutinib, a highly selective Bruton\u2019s tyrosine kinase inhibitor, by phosphoproteomics and transcriptomics. PLoS One. 2023; 18: e0282166.","DOI":"10.1371\/journal.pone.0282166"},{"key":"11","unstructured":"11 Ono Pharmaceutical Co., Ltd. Velexbru<sup>\u00ae<\/sup> (tirabrutinib) tablets 80 mg, pharmaceutical interview form. 10th Edition. 2025 [in Japanese]. https:\/\/www.info.pmda.go.jp\/go\/interview\/1\/180188_4291066F1029_1_010_1F.pdf. Accessed December 25, 2025."},{"key":"12","doi-asserted-by":"crossref","unstructured":"12 Sekiguchi N, Rai S, Munakata W <i>et al.<\/i> A multicenter, open-label, phase II study of tirabrutinib (ONO\/GS-4059) in patients with Waldenstr\u00f6m\u2019s macroglobulinemia. Cancer Sci. 2020; 111: 3327-3337.","DOI":"10.1111\/cas.14561"},{"key":"13","doi-asserted-by":"crossref","unstructured":"13 Sekiguchi N, Rai S, Munakata W <i>et al.<\/i> Two-year outcomes of tirabrutinib monotherapy in Waldenstr\u00f6m\u2019s macroglobulinemia. Cancer Sci. 2022; 113: 2085-2096.","DOI":"10.1111\/cas.15344"},{"key":"14","unstructured":"14 Pharmaceuticals and Medical Devices Agency. Review report: Velexbru<sup>\u00ae<\/sup> (tirabrutinib) tablets 80 mg. 2020. https:\/\/www.pmda.go.jp\/files\/000241167.pdf. Accessed March 11, 2025."},{"key":"15","doi-asserted-by":"crossref","unstructured":"15 Munakata W, Ando K, Hatake K <i>et al.<\/i> Phase I study of tirabrutinib (ONO-4059\/GS-4059) in patients with relapsed or refractory B-cell malignancies in Japan. Cancer Sci. 2019; 110: 1686-1694.","DOI":"10.1111\/cas.13983"},{"key":"16","doi-asserted-by":"crossref","unstructured":"16 Narita Y, Nagane M, Mishima K <i>et al.<\/i> Phase I\/II study of tirabrutinib, a second-generation Bruton\u2019s tyrosine kinase inhibitor, in relapsed\/refractory primary central nervous system lymphoma. Neuro Oncol. 2021; 23: 122-133.","DOI":"10.1093\/neuonc\/noaa145"},{"key":"17","doi-asserted-by":"crossref","unstructured":"17 Walter HS, Rule SA, Dyer MJS <i>et al.<\/i> A phase 1 clinical trial of the selective BTK inhibitor ONO\/GS-4059 in relapsed and refractory mature B-cell malignancies. Blood. 2016; 127: 411-419.","DOI":"10.1182\/blood-2015-08-664086"},{"key":"18","doi-asserted-by":"crossref","unstructured":"18 Owen RG, Kyle RA, Stone MJ <i>et al.<\/i> Response assessment in Waldenstr\u00f6m macroglobulinaemia: update from the VIth International Workshop. Br J Haematol. 2013; 160: 171-176.","DOI":"10.1111\/bjh.12102"},{"key":"19","doi-asserted-by":"crossref","unstructured":"19 Kawasaki A, Matsumoto I, Izutsu K, Nishikawa R. Post-marketing surveillance of tirabrutinib in 189 patients with r\/r primary central nervous system lymphoma. Future Oncol. 2025; 21: 1837-1847.","DOI":"10.1080\/14796694.2025.2507561"},{"key":"20","doi-asserted-by":"crossref","unstructured":"20 Estupi\u00f1\u00e1n HY, Bergl\u00f6f A, Zain R, Smith CIE. Comparative analysis of BTK inhibitors and mechanisms underlying adverse effects. Front Cell Dev Biol. 2021; 9: 630942.","DOI":"10.3389\/fcell.2021.630942"},{"key":"21","doi-asserted-by":"crossref","unstructured":"21 Owen RG, McCarthy H, Rule S <i>et al.<\/i> Acalabrutinib monotherapy in patients with Waldenstr\u00f6m macroglobulinemia: a single-arm, multicentre, phase 2 study. Lancet Haematol. 2020; 7: e112-e121.","DOI":"10.1016\/S2352-3026(19)30210-8"},{"key":"22","doi-asserted-by":"crossref","unstructured":"22 Tam CS, Opat S, D\u2019Sa S <i>et al.<\/i> A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstr\u00f6m macroglobulinemia: the ASPEN study. Blood. 2020; 136: 2038-2050.","DOI":"10.1182\/blood.2020006844"},{"key":"23","doi-asserted-by":"crossref","unstructured":"23 Futatani T, Watanabe C, Baba Y, Tsukada S, Ochs HD. Bruton\u2019s tyrosine kinase is present in normal platelets and its absence identifies patients with X-linked agammaglobulinaemia and carrier females. Br J Haematol. 2001; 114: 141-149.","DOI":"10.1046\/j.1365-2141.2001.02905.x"},{"key":"24","doi-asserted-by":"crossref","unstructured":"24 Zuber M, Borate SN, Gokhale P <i>et al.<\/i> Bruton tyrosine kinase inhibitor monotherapy in B-cell lymphoma and risk of infection: a systematic review and meta-analysis of randomized controlled trials. Hematol Oncol. 2024; 42: e3308.","DOI":"10.1002\/hon.3308"},{"key":"25","doi-asserted-by":"crossref","unstructured":"25 Brown JR, Eichhorst B, Hillmen P <i>et al.<\/i> Zanubrutinib or ibrutinib in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2023; 388: 319-332.","DOI":"10.1056\/NEJMoa2211582"},{"key":"26","doi-asserted-by":"crossref","unstructured":"26 Byrd JC, Hillmen P, Ghia P <i>et al.<\/i> Acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia: results of the first randomized phase III trial. J Clin Oncol. 2021; 39: 3441-3452.","DOI":"10.1200\/JCO.21.01210"},{"key":"27","doi-asserted-by":"crossref","unstructured":"27 Zanwar S, Kapoor P. Diagnosis and risk stratification in Waldenstr\u00f6m macroglobulinemia. J Natl Compr Canc Netw. 2024; 22: e247024.","DOI":"10.6004\/jnccn.2024.7024"}],"container-title":["Journal of Clinical and Experimental Hematopathology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/jslrt\/66\/2\/66_25054\/_pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,4]],"date-time":"2026-07-04T05:16:24Z","timestamp":1783142184000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/jslrt\/66\/2\/66_25054\/_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026]]},"references-count":27,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026]]}},"URL":"https:\/\/doi.org\/10.3960\/jslrt.25054","relation":{},"ISSN":["1346-4280","1880-9952"],"issn-type":[{"value":"1346-4280","type":"print"},{"value":"1880-9952","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026]]},"article-number":"25054"}}