{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T23:55:25Z","timestamp":1782863725009,"version":"3.54.5"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T00:00:00Z","timestamp":1772064000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T00:00:00Z","timestamp":1772064000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002973","name":"Daiichi Sankyo Co., Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002973","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Quizartinib is an oral, once-daily, highly potent and selective second-generation, type II FMS-like tyrosine kinase 3 (FLT3) inhibitor, approved for the treatment of newly diagnosed and relapsed\/refractory (R\/R)\n                    <jats:italic>FLT3<\/jats:italic>\n                    -internal tandem duplication (ITD)-positive acute myeloid leukemia (AML). This descriptive, observational post-marketing surveillance (PMS) investigated the safety of quizartinib in patients with R\/R\n                    <jats:italic>FLT3<\/jats:italic>\n                    -ITD-positive AML who initiated quizartinib between October 2019 and December 2021 in Japan. The safety analysis dataset included 126 patients (mean age 60.4\u00a0years) who consented to data publication. Eighty patients (63.5%) had previously received another FLT3 inhibitor. The median treatment duration was 71.0\u00a0days. Adverse drug reactions (ADRs) occurred in 68 patients (54.0%); grade\u2009\u2265\u20093 and serious ADRs occurred in 44 (34.9%) and 20 (15.9%) patients, respectively. QT interval prolongation occurred in 18\/124 patients (14.5%), and the first event typically occurred\u2009&lt;\u200930\u00a0days, but sometimes\u2009\u2265\u2009150\u00a0days, after quizartinib initiation; none of these patients experienced clinical symptoms associated with the ADR. This PMS showed that the safety profile of quizartinib in routine clinical practice in Japanese patients with R\/R\n                    <jats:italic>FLT3<\/jats:italic>\n                    -ITD-positive AML did not differ from the known safety profile of quizartinib. QT interval prolongation was manageable with current risk minimization measures.\n                  <\/jats:p>","DOI":"10.1007\/s12185-026-04181-7","type":"journal-article","created":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T09:05:31Z","timestamp":1772096731000},"page":"74-84","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Post-marketing surveillance of quizartinib for relapsed or refractory FLT3-ITD-positive acute myeloid leukemia in Japan"],"prefix":"10.1007","volume":"124","author":[{"given":"Yasushi","family":"Miyazaki","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itaru","family":"Matsumura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Arita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryouko","family":"Fukuda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mie","family":"Yamanaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,26]]},"reference":[{"key":"4181_CR1","doi-asserted-by":"publisher","first-page":"220","DOI":"10.1182\/asheducation-2013.1.220","volume":"2013","author":"M Levis","year":"2013","unstructured":"Levis M. FLT3 mutations in acute myeloid leukemia: What is the best approach in 2013? Hematol Am Soc Hematol Educ Prog. 2013;2013:220\u20136.","journal-title":"Hematol Am Soc Hematol Educ Prog"},{"key":"4181_CR2","doi-asserted-by":"publisher","first-page":"1025","DOI":"10.1016\/S1470-2045(15)00201-6","volume":"16","author":"F Ravandi","year":"2015","unstructured":"Ravandi F, Ritchie EK, Sayar H, Lancet JE, Craig MD, Vey N, et al. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2015;16:1025\u201336.","journal-title":"Lancet Oncol"},{"key":"4181_CR3","doi-asserted-by":"publisher","first-page":"939","DOI":"10.1038\/leu.2011.25","volume":"25","author":"P Chevallier","year":"2011","unstructured":"Chevallier P, Labopin M, Turlure P, Prebet T, Pigneux A, Hunault M, et al. A new leukemia prognostic scoring system for refractory\/relapsed adult acute myelogeneous leukaemia patients: a GOELAMS study. Leukemia. 2011;25:939\u201344.","journal-title":"Leukemia"},{"key":"4181_CR4","doi-asserted-by":"publisher","first-page":"1306","DOI":"10.1038\/leu.2017.23","volume":"31","author":"M Wattad","year":"2017","unstructured":"Wattad M, Weber D, D\u00f6hner K, Krauter J, Gaidzik VI, Paschka P, et al. Impact of salvage regimens on response and overall survival in acute myeloid leukemia with induction failure. Leukemia. 2017;31:1306\u201313.","journal-title":"Leukemia"},{"key":"4181_CR5","doi-asserted-by":"publisher","first-page":"2984","DOI":"10.1182\/blood-2009-05-222034","volume":"114","author":"PP Zarrinkar","year":"2009","unstructured":"Zarrinkar PP, Gunawardane RN, Cramer MD, Gardner MF, Brigham D, Belli B, et al. AC220 is a uniquely potent and selective inhibitor of FLT3 for the treatment of acute myeloid leukemia (AML). Blood. 2009;114:2984\u201392.","journal-title":"Blood"},{"key":"4181_CR6","doi-asserted-by":"publisher","first-page":"984","DOI":"10.1016\/S1470-2045(19)30150-0","volume":"20","author":"JE Cortes","year":"2019","unstructured":"Cortes JE, Khaled S, Martinelli G, Perl AE, Ganguly S, Russell N, et al. Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2019;20:984\u201397.","journal-title":"Lancet Oncol"},{"key":"4181_CR7","doi-asserted-by":"publisher","first-page":"1571","DOI":"10.1016\/S0140-6736(23)00464-6","volume":"401","author":"HP Erba","year":"2023","unstructured":"Erba HP, Montesinos P, Kim HJ, Patkowska E, Vrhovac R, \u017d\u00e1k P, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;401:1571\u201383.","journal-title":"Lancet"},{"key":"4181_CR8","unstructured":"US Food and Drug Administration. VANFLYTA Prescribing information. 2023. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/216993s000lbl.pdf. Accessed 14 Aug 2024."},{"key":"4181_CR9","unstructured":"Daiichi Sankyo Inc. VANFLYTA\u00ae first FLT3 inhibitor approved in the U.S. specifically for patients with newly diagnosed FLT3-ITD positive AML. Press release. 2023. https:\/\/www.daiichisankyo.com\/files\/news\/pressrelease\/pdf\/202307\/20230720_E.pdf. Accessed 20 Jan 2025."},{"key":"4181_CR10","unstructured":"European Medicines Agency. VANFLYTA Summary of product characteristics. 2023. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/vanflyta-epar-product-information_en.pdf. Accessed 14 Aug 2024."},{"key":"4181_CR11","unstructured":"Daiichi Sankyo Inc. VANFLYTA\u00ae approved in the EU as the first FLT3 inhibitor specifically for patients with newly diagnosed FLT3-ITD positive AML. Press release. 2023. https:\/\/www.daiichisankyo.com\/files\/news\/pressrelease\/pdf\/202311\/20231109_E.pdf. Accessed 20 Jan 2025."},{"key":"4181_CR12","unstructured":"Medicines & Healthcare products Regulatory Agency (MHRA). Quizartinib approved to treat adult patients with a type of blood cancer. 2024. https:\/\/www.gov.uk\/government\/news\/quizartinib-approved-to-treat-adult-patients-with-a-type-of-blood-cancer. Accessed 20 Jan 2025."},{"key":"4181_CR13","unstructured":"Medicines & Healthcare products Regulatory Agency (MHRA). VANFLYTA\u00ae (quizartinib) summary of product characteristics. 2024. https:\/\/products.mhra.gov.uk\/substance\/?substance=QUIZARTINIB%20DIHYDROCHLORIDE Accessed 20 Jan 2025."},{"key":"4181_CR14","unstructured":"Daiichi Sankyo Inc. VANFLYTA\u00ae first FLT3 inhibitor approved in Japan for patients with newly diagnosed FLT3-ITD positive AML. Press release. 2023. https:\/\/www.daiichisankyo.com\/files\/news\/pressrelease\/pdf\/202305\/20230525_E.pdf. Accessed 20 Jan 2025."},{"key":"4181_CR15","unstructured":"Daiichi Sankyo Inc. Daiichi Sankyo launches FLT3 inhibitor VANFLYTA\u00ae in Japan for the treatment of patients with relapsed\/refractory FLT3-ITD AML. Press release. 2019. https:\/\/www.daiichisankyo.com\/media\/press_release\/detail\/index_3169.html. Accessed 20 Jan 2025."},{"key":"4181_CR16","unstructured":"Pharmaceutical and Medical Devices Agency. Report on the deliberation results. Vanflyta tablets. 2019. https:\/\/www.pmda.go.jp\/files\/000240288.pdf. Accessed 24 June 2024."},{"key":"4181_CR17","doi-asserted-by":"publisher","first-page":"513","DOI":"10.1007\/s00280-020-04204-y","volume":"87","author":"D Kang","year":"2021","unstructured":"Kang D, Ludwig E, Jaworowicz D, Huang H, Fiedler-Kelly J, Cortes J, et al. Concentration-QTc analysis of quizartinib in patients with relapsed\/refractory acute myeloid leukemia. Cancer Chemother Pharmacol. 2021;87:513\u201323.","journal-title":"Cancer Chemother Pharmacol"},{"key":"4181_CR18","doi-asserted-by":"publisher","first-page":"3681","DOI":"10.1200\/JCO.2013.48.8783","volume":"31","author":"JE Cortes","year":"2013","unstructured":"Cortes JE, Kantarjian H, Foran JM, Ghirdaladze D, Zodelava M, Borthakur G, et al. Phase I study of quizartinib administered daily to patients with relapsed or refractory acute myeloid leukemia irrespective of FMS-like tyrosine kinase 3-internal tandem duplication status. J Clin Oncol. 2013;31:3681\u20137.","journal-title":"J Clin Oncol"},{"key":"4181_CR19","doi-asserted-by":"publisher","first-page":"889","DOI":"10.1016\/S1470-2045(18)30240-7","volume":"19","author":"J Cortes","year":"2018","unstructured":"Cortes J, Perl AE, D\u00f6hner H, Kantarjian H, Martinelli G, Kovacsovics T, et al. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018;19:889\u2013903.","journal-title":"Lancet Oncol"},{"key":"4181_CR20","doi-asserted-by":"publisher","first-page":"665","DOI":"10.1007\/s12185-019-02727-6","volume":"110","author":"T Takahashi","year":"2019","unstructured":"Takahashi T, Usuki K, Matsue K, Ohno H, Sakura T, Imanaka R, et al. Efficacy and safety of quizartinib in Japanese patients with FLT3-ITD positive relapsed or refractory acute myeloid leukemia in an open-label, phase 2 study. Int J Hematol. 2019;110:665\u201374.","journal-title":"Int J Hematol"}],"container-title":["International Journal of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-026-04181-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12185-026-04181-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-026-04181-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T23:11:59Z","timestamp":1782861119000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12185-026-04181-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,26]]},"references-count":20,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["4181"],"URL":"https:\/\/doi.org\/10.1007\/s12185-026-04181-7","relation":{},"ISSN":["0925-5710","1865-3774"],"issn-type":[{"value":"0925-5710","type":"print"},{"value":"1865-3774","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,26]]},"assertion":[{"value":"1 September 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 February 2026","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 February 2026","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 February 2026","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Yasushi Miyazaki reports support for the present manuscript from Daiichi Sankyo Co., Ltd.; payment or honoraria for lectures, presentations, speakers\u2019 bureaus, manuscript writing, or educational events from Daiichi Sankyo Co., Ltd., Astellas, Novartis, Sumitomo Pharma, Bristol Myers Squibb, AbbVie, and Chugai Pharmaceutical Co., Ltd; a leadership or fiduciary role for the Japan Adult Leukemia Study Group; and membership of the\n                      International Journal of Hematology\n                      Editorial Board. Itaru Matsumura reports grants or contracts from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Eisai Co., Ltd., AbbVie GK, Asahi Kasei Pharma Corporation, Sumitomo Pharma, Taiho Pharmaceutical Co., Ltd., and Otsuka Pharmaceutical Co., Ltd; consulting fees from Otsuka Pharmaceutical Co., Ltd.; and payment or honoraria for lectures, presentations, speakers\u2019 bureaus, manuscript writing, or educational events from Chugai Pharmaceutical Co., Ltd, Novartis Pharma, Novartis, Pfizer Japan, AbbVie, Ono Pharmaceutical Co., Ltd., Sanofi, AstraZeneca, Bristol-Myers Squibb, Janssen Pharmaceuticals, Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., SymBio Pharmaceuticals Ltd., and Astellas Pharma. Takeshi Arita has no conflicts of interest to declare. Ryouko Fukuda and Mie Yamanaka are employees of Daiichi Sankyo Co., Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}