奎扎替尼(Quizartinib Hydrochloride) - 药物靶点：FLT3_在研适应症：急性髓性白血病，伴有 FLT3/ITD 突变的急性髓系白血病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

N-(5-(1,1-Dimethylethyl)isoxazol-3-yl)-N'-(4-(7-(2-(morpholin-4-yl)ethoxy)imidazo(2,1-b)benzothiazol-2-yl)phenyl)urea、Quizartinib

+ [8]

靶点

FLT3

作用机制

FLT3抑制剂(酪氨酸蛋白激酶受体FLT3抑制剂)

治疗领域

肿瘤血液及淋巴系统疾病

在研适应症

急性髓性白血病伴有 FLT3/ITD 突变的急性髓系白血病

非在研适应症

急性淋巴细胞白血病晚期恶性实体瘤FLT3阳性急性髓性白血病+ [5]

原研机构

Ambit Biosciences Corp.

在研机构

Daiichi Sankyo, Inc.徕博科医药研发(北京)有限公司

Daiichi Sankyo Europe GmbH

+ [2]

非在研机构

Ambit Biosciences Corp.

Anderson University

最高研发阶段批准上市

首次获批日期

日本 (2019-06-18),

伴有 FLT3/ITD 突变的急性髓系白血病

最高研发阶段(中国)临床3期

特殊审评特殊审批 (中国)、快速通道 (美国)、突破性疗法 (美国)、孤儿药 (美国)、优先审评 (美国)

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结构

分子式C29H34Cl2N6O4S

InChIKeyDHYPGRVMIOATAE-UHFFFAOYSA-N

CAS号1132827-21-4

关联

47

项与奎扎替尼相关的临床试验

NCT06578247 / Not yet recruiting临床3期

Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

开始日期2024-10-30

申办/合作机构

Daiichi Sankyo Co., Ltd.

CTIS2023-505000-27-01 / RecruitingIIT

A phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric FLT3-ITD positive and NPM1 wild-type AML patients (A linked-trial of the CHIP-AML22/Master protocol by the NOPHO-DB-SHIP consortium) - MH22CAQ

开始日期2024-02-06

申办/合作机构-

NCT06262438 / Recruiting临床2期IIT

A Phase II, Single Arm, Open Label, Study on the Safety, Efficacy, Pharmacokinetics & Pharmacodynamics of Quizartinib + Chemotherapy and as Single-agent After High Dose Therapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients

The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is a phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type.

开始日期2024-02-06

申办/合作机构

Princess Maxima Centre For Pediatric Oncology

[+1]

100 项与奎扎替尼相关的临床结果

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100 项与奎扎替尼相关的转化医学

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100 项与奎扎替尼相关的专利（医药）

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333

项与奎扎替尼相关的文献（医药）

2024-12-01·Recent Patents on Anti-Cancer Drug Discovery

Integrating Bioinformatics and Drug Sensitivity Analyses to Identify Molecular Characteristics Associated with Targeting Necroptosis in Breast Cancer and their Clinical Prognostic Significance

Article

作者: Zheng, Chang ; Mo, Yongpan ; Guo, Hanbin ; Liu, Guowen

Background:Breast cancer accounts for over 1.8 million new cases worldwide annually, and prompt diagnosis and treatment are imperative to prevent mortality. Necroptosis, a form of programmed cell death, is thought to be a critical pathway for cancer cell apoptosis, yet, its relationship with breast cancer progression and molecular mechanisms remains largely unexplored.Objectives:Our study aims to investigate the molecular characteristics and clinical prognostic value of necroptosis-related genes in breast cancer using a comprehensive approach that involves integrated bioinformatics analysis along with drug sensitivity assessment.Methods:Transcriptional, clinical, and tumor mutation burden (TMB) data related to breast cancer from the TCGA and GEO databases were integrated, and the necroptosis gene set was downloaded from the GSEA website for analysis. The screening conditions were set as adjusted p < 0.05 and |log2FC(fold change)| > 0.585 to screen for differential expression genes related to breast cancer necroptosis. Survival prognosis analysis was conducted on breast cancer necroptosis genes. Further analysis was conducted on prognosis-related necroptosis genes, including immune infiltration analysis and GO/KEGG enrichment analysis, to explore the potential biological functions and signaling pathway mechanisms of breast cancer necroptosis genes. Drug sensitivity screening was conducted on the prognosis-related necroptosis to identify potential drugs that target the promotion of necroptosis gene expression, and ultimately, single-gene analysis was performed on the core target genes obtained.Results:Through integrated bioinformatics analysis, 29 differentially expressed mRNAs related to BRCA-Necroptosis were identified, including 18 upregulated mRNAs and 11 downregulated mRNAs. In addition, single-factor analysis of differential genes showed that the expression of HSPA4, PLK1, TNFRSF1B, FLT3, and LEF1 was closely related to BRCA survival prognosis. Based on the expression of these genes, a breast cancer prognosis model was constructed, and it was found that the area under the curve (AUC) of the curve of the risk genes for necroptosis was the largest, indicating that these genes have a certain clinical predictive significance for the occurrence and prognosis of BRCA. Additionally, there were significant differences in clinical characteristics of BRCA patients with different necroptosis gene expressions. Furthermore, GSVA and immune infiltration analysis revealed that Necroptosis-DEGs mainly affect the occurrence and progression of BRCA by participating in immune functions such as APC co-inhibition, APC co-stimulation, CCR, checkpoint, as well as infiltrating immune cells such as B cells naive, plasma cells, and T cells CD8. Moreover, the necroptosis gene group column chart indicated a 1-year survival rate of 0.979, a 3-year survival rate of 0.883, and a 5-year survival rate of 0.774. The necroptosis gene group and column chart are important indicators for evaluating BRCA prognosis. Finally, drug sensitivity screening of BRCA-Necroptosis genes showed that compounds such as A-770041, AC220, AP-24534, Bexarotene, and BMS-509744 have certain effects as potential targeted drugs for the treatment of BRCA necroptosis genes.Conclusion:Necroptosis genes are implicated in the pathogenesis and progression of breast cancer and are thought to impact the prognosis and response to drug treatments in individuals with BRCA. Consequently, understanding the role of these genes in breast cancer may aid in identifying more precise and efficacious therapeutic targets.

2024-12-01·European Journal of Medicinal Chemistry

Identification of furo[2,3-d]pyrimidin-4-ylsulfanyl-1,3,4-thiadiazole derivatives as novel FLT3-ITD inhibitors

Article

作者: Moradi, Mahfam ; Foroumadi, Alireza ; Firoozpour, Loghman ; Peřina, Miroslav ; Mousavi, Alireza ; Emamgholipour, Zahra ; Grúz, Jiří ; Peytam, Fariba ; Jorda, Radek ; Sadat-Ebrahimi, Seyed Esmaeil ; Vojáčková, Veronika ; Kryštof, Vladimír ; Řezníčková, Eva

Given the significant prevalence of FLT3 receptor and its mutations in acute myeloid leukemia (AML) pathogenesis, we present a novel series of furo[2,3-d]pyrimidin-1,3,4-thiadiazole-urea derivatives, designed to exhibit FLT3-ITD inhibitory activity. These compounds demonstrated cytotoxicity in FLT3-ITD expressing AML cell lines MOLM-13 and MV4-11 in the nanomolar range, with significant selectivity over the K562 cell line. In-depth evaluations of example compound 49 revealed its efficacy in suppressing FLT3 phosphorylation and the downstream signaling molecules, including STAT5 and ERK1/2. Notably, compound 49 demonstrated cytotoxic effects in Ba/F3 cells expressing FLT3-ITD or FLT3-ITD-F691L mutant, exceeding the potency of both sorafenib and quizartinib. Molecular docking studies suggest that this compound binds to the active site of FLT3 in a type II manner. The study suggests that substituted furo[2,3-d]pyrimidines could be useful additions to the growing field of FLT3-targeted therapy for AML. These compounds have the potential to serve as novel FLT3-ITD inhibitors and may offer insights for developing future therapeutic strategies in AML.

2024-11-07·Future Oncology

Quizartinib: a new hope in acute myeloid leukemia, an applied comprehensive review

Review

作者: Karimi, Mohammad Amin ; Gholami Chahkand, Mohammad Sadra ; Shahrokhi, Mehregan ; Dadkhah, Parisa Alsadat ; Deyhimi, Mitra Sadat ; Azarm, Eftekhar ; Moallem, Fatemeh Esmaeilpour

Acute myeloid leukemia (AML) is caused by a defective precursor leading to malignant clonal expansion, often with FMS-like tyrosine kinase-3 receptor (FLT3) mutations, particularly internal tandem duplication (ITD), which has a poor prognosis. Quizartinib, a second-generation FLT3 inhibitor, has FDA approval for relapsed/refractory AML with FLT3/ITD mutation. It has shown promise in clinical studies since 2013 due to its excellent oral absorption and potent activity on FLT3. This review explores Quizartinib's mechanism of action, efficacy in monotherapy or combination with chemotherapy, drug interactions, adverse events, resistance mechanisms and future research directions.

84

项与奎扎替尼相关的新闻（医药）

2024-10-23

·E药经理人

解码第一三共中国战略，如何领拓ADC新时代？｜专访第一三共（中国）总裁内田祥夫

又逢一年CSCO年会（中国临床肿瘤学会年会），第一三共再携多项重磅研发成果亮相CSCO。紧随2023年先后获批用于治疗HER2晚期乳腺癌以及HER2低表达转移性乳腺癌，2024年又拿下胃癌及肺癌两大适应症，优赫得®（DS8201，T-DXd，德曲妥珠单抗）正式进军消化道及呼吸系统肿瘤领域。第一三共犹如一匹“黑马”，正在通过优赫得®作为开路先锋，持续注入TROP2 靶向ADC Dato-DXd、HER3靶向ADC HER3-DXd等多个创新ADC新势力，在中国抗肿瘤赛道屡获突破，引领中国抗肿瘤治疗市场的革新浪潮。借助CSCO大会召开的契机，E药经理人特邀第一三共（中国）总裁内田祥夫进行深度对话，剖析第一三共中国发展战略，以及未来第一三共还将如何助益健康中国事业的规划。他表示：“我们始终相信先进的科学和技术手段是帮助患者走出疾病阴影的关键，也是第一三共在肿瘤领域的核心差异化优势，将持续加速创新产品惠及患者。” 01 屡破新局，确立优势地位回顾优赫得®在中国抗肿瘤治疗领域的一系列开疆拓土，这张第一三共的王牌，迅速成为重磅炸弹产品的背后，其实是对于人类健康事业的贡献。这一点在优赫得®一次次的治疗突破上得以具像化。国家卫生健康委等发布《健康中国行动—癌症防治行动实施方案（2023-2030年）》，提出的“要在2030年总体癌症5年生存率提高到46.6%”[1]目标成为此后我国抗肿瘤治疗事业的共同追求。同时，随着人口老龄化的加速以及生活方式的变迁，公众对恶性肿瘤的预防和治疗需求也在不断攀升。优赫得®进入中国市场的两年时间，接连获批的四项具有突破性意义的适应症，其所带来的临床价值，都与“健康中国2030”规划的目标以及公众日益增长的健康需求不谋而合。回顾第一三共对于优赫得®的布局与成果，第一次惊艳业界是在与恩美曲妥珠单抗的头对头随机对照研究成果发布之际，优赫得®以更显著的总生存期、中位无进展生存期和安全性获益改写了全球的HER2阳性晚期乳腺癌二线治疗标准。紧接着，优赫得®又获批HER2低表达转移性乳腺癌适应症，使得乳腺癌治疗从传统的非阴即阳二分法时代迈入更加精准的三分法时代（阳性/低表达/阴性），不仅扩大了受益人群，更是推动整个抗HER2乳腺癌治疗模式的革新。而这两项成果也在2023年登陆中国，帮助中国的乳腺癌治疗接轨国际，为中国乳腺癌患者带来更长的生存时间和更高的生活质量。要知道，乳腺癌在中国的发病率已经比肩肺癌，在2022年我国的乳腺癌新发病例数达35.72万人[2]。在乳腺癌群体中，更是有多达45%-55%的患者为HER2低表达乳腺癌[3]，且过往她们能获得的治疗手段和效果都非常有限，因此优赫得®的重大意义不言而喻。而在胃癌领域，优赫得®同样续写了它的“传奇”故事。针对HER2阳性晚期胃癌患者，过往疗法长期囿于“仅仅是延长了总生存期，一线治疗后疾病进展的患者中位生存期（mOS）难以突破”的治疗困境。此时，第一三共交出了支持优赫得®在全球超过65个国家/地区获批的DESTINY-Gastric01研究数据：与化疗相比，德曲妥珠单抗组的mOS达到12.5个月，客观缓解率(ORR)也保持在51.3%[4]。并且，在中国人群中进行的试验DESTINY-Gastric06也取得了DESTINY-Gastric01研究一致的临床获益及持久的抗肿瘤活性[5]。因此在今年8月，优赫得®治疗HER2阳性晚期胃癌适应症在中国获批，同时，早在今年4月，德曲妥珠单抗还正式被纳入《CSCO胃癌诊疗指南2024》HER2阳性晚期胃癌三线及三线以上治疗的III级推荐[6]。至此，优赫得®再次确立在HER2阳性胃癌治疗领域的优势地位。今年10月，优赫得®肺癌适应症在中国获批，单药适用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者，为中国肺癌患者带来了治疗新希望。内田祥夫表示：“面对不断增长的临床需求，第一三共（中国）深耕肿瘤市场，聚焦在乳腺癌、肺癌、胃癌等严重威胁中国患者健康、且具有巨大临床需求的高发癌种上，不断加大投资和研发力度，依托集科学和技术为一体的DXd ADC独特平台，领拓ADC药物的创新研发，打破医学的‘无人区’。” 02 平台积淀，引领行业前沿近年来，无论是各大药企披露的重磅研究成果，还是每每刷新纪录的BD/并购交易金额，ADC项目无疑都是其中炙手可热的明星。而第一三共自世纪交接之时积淀至今的研发平台，在产品与适应症上的横纵布局，以及研发的迅猛速度，使其始终在广大“玩家”之中保持优势地位，并站在行业前沿。根据内田祥夫介绍，依托独有的DXd ADC 技术平台，目前共有 6 款新药临床在研，包括HER2靶向ADC德曲妥珠单抗即优赫得®、TROP2 靶向ADC Dato-DXd、HER3靶向ADC HER3-DXd，B7-H3 靶向 ADC I-DXd，CDH6 靶向ADC R-DXd，以及TA-MUC1靶向ADC DS-3939。这6款ADC新药横向揽括肺癌、乳腺癌、胃癌、胆道癌、前列腺癌等高发癌种，纵向布局后线、前线、辅助、新辅助治疗全面覆盖。同时，第一三共还与阿斯利康、默沙东等大型MNC达成共同开发和全球范围商业化的合作，提升更多患者的可及性和可负担性。其中，德曲妥珠单抗、Dato-DXd 正在由第一三共与阿斯利康共同开发并在全球范围内商业化；HER3-DXd，I-DXd以及R-DXd由第一三共与默沙东共同开发并在全球范围内商业化。当然，第一三共ADC新药屡破治疗格局、交出亮眼数据，并获得业界认可，离不开第一三共所打造的独有DXd ADC技术平台和严密的专利布局，这也是第一三共长期保持关键优势的原因。据悉，第一三共的ADC研发最早可追溯至40年前，组成ADC的核心三大要素——抗体选择、连接子和细胞毒物，都是经过第一三共科学家长达数十年精心打磨，最终形成了独特的DXd ADC技术平台。基于该平台研发的肿瘤ADC药物在药物结构上得以突破，形成独特的治疗优势。即便已经凭借DXd ADC技术平台，形成了具有竞争性的优势，第一三共也从未停下对创新的探索。例如在近期召开的欧洲肿瘤内科学会（ESMO）上，第一三共首次发布基于其新一代ADC技术平台的DS-9606的一期研究数据。DS-9606是一种靶向CLND6、由改良吡咯并苯并二氮杂卓（PBD）构建的ADC药物。此外，除ADC药物外，第一三共所开发的靶向治疗药物Quizartinib也已在美国、欧盟和日本获批治疗急性髓系白血病（AML），在中国针对腱鞘巨细胞瘤（TGCT）的小分子靶向药物的研发也在进行中。 03 目标导向，专注患者福祉 2023年，优赫得®在全球取得了非常亮眼的商业成绩，2024年更是有望再攀高峰。同时，Dato-DXd和HER3-DXd也先后在美国FDA、欧盟EMA提交了上市申请并获受理，在不久的将来会与优赫得®形成协同效应，夯实第一三共在全球ADC抗肿瘤市场的优势。这些成绩的背后，其实是强烈目标感的引导。内田祥夫表示，“成为‘在肿瘤领域具有竞争优势的全球制药创新者’和到2030年成为‘为社会可持续发展做出贡献的创新型全球医疗保健公司’的目标，我们使命必达。” 接下来，根据第一三共的五年商业计划，从2021到2025年，公司还将持续加大全球研发投入，用于确保ADC创新产品的开发。“我们还积极推进在生物制药领域建立更强大的生产和供应体系，引入数字技术，搭建基于数据可视化和数据集成的‘智能供应链’，确保药物供应效率和规模。” 在实现目标的过程中，中国市场之于第一三共商业计划的重要价值，也再难掩其锋芒本质。一方面，作为拥有14亿人口数量的大国，公众对于创新药的强烈需求日益增长。另一方面，中国政策端对于创新药物临床转化落地的有力引导和全方位支持，以及药品审评审批系列政策的持续优化，也让中国创新药市场进入黄金发展周期。种种因素的影响下，中国已经跃居全球第二大医药市场。不过，中国ADC赛道的竞争激烈程度也不容忽视，仅统计本土ADC药物的研发数量，就已居全球第二。因此，对于第一三共而言，中国市场庞大的临床需求与卓越的营商环境，使其成为第一三共最重要的战略核心之一。同时，面对激烈的竞争，第一三共正致力于使中国成为全球关键的研发中心之一。据悉，中国的研发团队已经全面参与第一三共多个DXd ADC药物及后续产品的临床开发中，开展临床研究超过30项，涉及乳腺癌、胃癌、肺癌等多个癌种的治疗。现如今，加速将科学成果转化为中国患者福祉，持续为中国患者带来突破性疗法，早已成为内田祥夫重要的工作日程之一。他表示，“未来，第一三共还将不断强化中国开发的参与机制，致力于让中国研发团队成为第一三共集团全球开发计划的第一梯队，逐步加入全球早期临床研究开发之中，让中国创新更深入地融入全球价值链。” 参考资料： [1] 国家卫生健康委等部门，《健康中国行动—癌症防治行动实施方案（2023-2030年）》 [2] https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834 [3] Tarantino P，Hamilton E，Tolaney S M，et al.HER2-low breast cancer:pathological and clinical landscape[J].Journal of Clinical Oncology，2020，38(17):1951-1962. [4] Shitara K,Bang YJ,Iwasa S,et al;DESTINY-Gastric01 Investigators.Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer.N Engl J Med.2020 Jun 18;382(25):2419-2430. [5] Zhi Peng, et al. ESMO ASIA 2023 abstract 172P. [6] CSCO指南工作委员会. CSCO胃癌诊疗指南2024 一审| 黄佳二审| 李芳晨三审| 李静芝

抗体药物偶联物CSCO会议申请上市突破性疗法临床申请

2024-09-20

·Pharmaceutical Technology

NHS England to offer Daiichi Sankyo’s quizartinib for AML

The decision to offer the product for acute myeloid leukaemia patients with the FLT3-ITD mutation follows a cost-effectiveness assessment by NICE. Credit: Nemes Laszlo/Shutterstock. The National Health Service (NHS) England has announced the routine commissioning of Daiichi Sankyo ‘s quizartinib for acute myeloid leukaemia (AML) patients with the FLT3-ITD mutation. The decision, facilitated by the Cancer Drugs Fund, will enable immediate access to the life-extending daily tablet, which has been shown to improve remission and survival rates significantly. The treatment, now available for prescription, is intended to be used in conjunction with chemotherapy for newly-diagnosed adult patients and may be continued as a maintenance treatment for up to three years to minimise the relapse risk. For patients showing significant improvement following quizartinib treatment, a stem cell transplant will be offered. For those ineligible for stem cell transplants, the tablet could still offer a substantial benefit by prolonging life. See Also: Gavi to obtain 500,000 mpox vaccine doses from Bavarian Nordic Valneva eyes teenage label for chikungunya vaccine in Europe and Canada The UK’s Medicines and Healthcare products Regulatory Agency previously confirmed the asset’s safety and efficacy, citing a median overall survival of 31.9 months with quizartinib against just 15.1 months in the placebo arm. Quizartinib works by specifically inhibiting the enzyme that drives uncontrollable cell growth in the bone marrow associated with AML with the FLT3-ITD mutation. NHs England’s decision to offer the product follows a cost-effectiveness assessment by the National Institute for Health and Care Excellence (NICE), which endorsed its use after Daiichi Sankyo proposed a reasonable price. NHS Cancer national clinical director Professor Peter Johnson stated: “It’s very good news that patients with this type of leukaemia now have an option that helps their chemotherapy to work better, boosting their chance of remission and long-term survival and offering them precious extra time with their families and friends. “People who have acute myeloid leukaemia and the specific FLT-3 ITD abnormality will be able to take this oral treatment, quizartinib, which the NHS has fast-tracked. “The NHS in England has an enviable track record of making innovative treatments available and this is the latest in a long list of new cancer drugs to help people live with and beyond cancer, making life-changing differences to people affected by cancer and their families across the country.”

疫苗上市批准

2024-09-19

·PMLiVE

Daiichi Sankyo’s Vanflyta recommended by NICE for acute myeloid leukaemia

Daiichi Sankyo’s Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for certain cases of acute myeloid leukaemia (AML). The drug has been specifically recommended for routine NHS commissioning in England and Wales as an induction, consolidation and maintenance therapy for newly diagnosed FLT3-ITD-positive disease. Approximately 18,000 people are diagnosed with AML, a type of blood cancer that starts from young white blood cells in the bone marrow, every year in Europe. FLT3-ITD mutations occur in up to 30% of all AML cases and are associated with an increased risk of relapse and shorter overall survival. Vanflyta, taken orally once daily, is the first selective FLT3 inhibitor to be approved in the UK for newly diagnosed FLT3-ITD-positive AML. NICE’s decision on the drug follows an approval from the Medicines and Healthcare products Regulatory Agency in March and was supported by positive results from the late-stage QuANTUM-First trial. Results from the study showed that Vanflyta in combination with standard induction and consolidation chemotherapy, and then continued as a maintenance monotherapy, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone. Median overall survival was 31.9 months for patients receiving Vanflyta versus 15.1 months for those in the control arm at a median follow-up of 39.2 months. Commenting on the recommendation, Haran Maheson, head of UK oncology and vice president, Daiichi Sankyo UK, said: “We are proud to have worked with NICE and NHS England to secure the first reimbursement for [Vanflyta] following health technology assessment in Europe. “UK patients with newly diagnosed FLT3-ITD positive AML can now receive a selective targeted therapy for their disease for the first time.” Sharing a similar sentiment, Colin Dyer, chief executive of UK charity Leukaemia Care, said: “We welcome the decision by NICE to approve this treatment… Patients with FLT3-ITD mutations have an increased risk of relapse with standard treatments, so another targeted treatment option for such patients is important for clinicians to tailor treatment plans to their patients effectively.”

临床结果上市批准

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外链

KEGG	Wiki	ATC	Drug Bank
-	奎扎替尼	L01XE52	DB12874

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适应症	国家/地区	公司	日期
急性髓性白血病	英国	Daiichi Sankyo UK Ltd.	2024-03-12
伴有 FLT3/ITD 突变的急性髓系白血病	日本	Daiichi Sankyo Co., Ltd.	2019-06-18

未上市

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适应症	最高研发状态	国家/地区	公司	日期
FLT3阳性急性髓性白血病	临床2期	捷克	Daiichi Sankyo, Inc.	2014-05-01
FLT3阳性急性髓性白血病	临床2期	比利时	Daiichi Sankyo, Inc.	2014-05-01
FLT3阳性急性髓性白血病	临床2期	法国	Daiichi Sankyo, Inc.	2014-05-01
FLT3阳性急性髓性白血病	临床2期	美国	Daiichi Sankyo, Inc.	2014-05-01
FLT3阳性急性髓性白血病	临床2期	塞尔维亚	Daiichi Sankyo, Inc.	2014-05-01
FLT3阳性急性髓性白血病	临床2期	韩国	Daiichi Sankyo, Inc.	2014-05-01
FLT3阳性急性髓性白血病	临床2期	英国	Daiichi Sankyo, Inc.	2014-05-01
FLT3阳性急性髓性白血病	临床2期	波兰	Daiichi Sankyo, Inc.	2014-05-01
FLT3阳性急性髓性白血病	临床2期	意大利	Daiichi Sankyo, Inc.	2014-05-01
急性淋巴细胞白血病	临床2期	英国	-	2011-05-12

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02668653 (QuANTUM-First, ASH2024)	临床3期	FLT3阳性急性髓性白血病 FLT3-ITD-positive \| NPM1 \| CEBPA ... 更多	518	Quizartinib	(範膚夢鏇鹹遞艱憲築選) = 窪醖憲餘淵願襯淵鹽糧醖艱遞築顧鏇獵憲網構 (衊獵膚鹽艱艱壓糧鬱醖 ) 更多	积极	2024-12-09
				Placebo	(範膚夢鏇鹹遞艱憲築選) = 窪簾淵繭夢鏇鹽壓醖夢醖艱遞築顧鏇獵憲網構 (衊獵膚鹽艱艱壓糧鬱醖 ) 更多
ASH2024	N/A	伴有 FLT3/ITD 突变的急性髓系白血病	-	Midostaurin	(憲獵網膚鹹製積遞鏇鏇) = 築鏇蓋壓鏇鹽觸衊簾願積積選積製製膚衊艱窪 (廠選鏇膚艱選製襯築壓 ) 更多	-	2024-12-09
				Quizartinib	(憲獵網膚鹹製積遞鏇鏇) = 齋膚衊憲顧廠獵膚網鏇積積選積製製膚衊艱窪 (廠選鏇膚艱選製襯築壓 ) 更多
ASH2024	N/A	伴有 FLT3/ITD 突变的急性髓系白血病	-	Quizartinib	壓蓋選窪顧積窪窪獵顧(構製積觸範選齋淵鬱繭) = In the R/R cohort, grade ≥3 non-hematologic toxicities regardless of attribution, in >10% of pts, included pneumonia (73%), neutropenic fever (53%), sepsis (18%), other infections involving the skin (18%)bacteremia (15%), and gastrointestinal tract (13%), with 8% experiencing grade 3 QTcF prolongations. Grade ≥3 non-hematologic toxicities was less common in the frontline cohort, with pneumonia (40%), neutropenic fever (50%), sepsis (10%), bacteremia (20%), and no grade 3 QTcF prolongations observed. 窪鏇壓鏇壓積壓廠鬱製 (醖獵網壓顧壓衊餘顧鹽 )	-	2024-12-09
				Venetoclax
ASH2024	N/A	FLT3阳性急性髓性白血病	-	Quizartinib	(膚壓選獵築糧壓窪齋繭) = 夢淵顧鹽壓製壓構壓艱廠鏇糧鑰齋膚積艱鹽糧 (齋獵構鑰艱觸繭簾選獵 ) 更多	-	2024-12-08
				Placebo	(膚壓選獵築糧壓窪齋繭) = 遞製壓構遞夢醖繭壓願廠鏇糧鑰齋膚積艱鹽糧 (齋獵構鑰艱觸繭簾選獵 ) 更多
NCT03735875 (CTgov)	临床1/2期	复发性急性髓细胞白血病 \| 伴有 FLT3/ITD 突变的急性髓系白血病 \| 难治性急性髓细胞白血病 \| 难治性急性白血病	8	Venetoclax+Quizartinib (Phase I: Treatment (Venetoclax, Quizartinib))	窪鑰憲願齋獵廠壓鏇網(築製壓衊願醖壓觸艱鹹) = 顧壓製遞襯窪廠夢鹹鏇繭鹽願憲鏇顧艱蓋夢膚 (範顧齋築顧膚窪糧膚築, 繭膚構蓋餘餘鑰齋選觸 ~ 願膚艱鹽繭餘網願願網) 更多	-	2024-09-19
				Venetoclax+Quizartinib (Phase II: Treatment (Venetoclax, Quizartinib))	構醖蓋鬱鹽襯窪選築網(壓網醖壓網鹹蓋蓋淵壓) = 齋願觸糧顧願齋窪膚構餘糧鏇築淵觸廠簾淵鬱 (鹹鏇壓齋淵網觸築鏇窪, 衊窪膚顧鏇窪鹹鹹觸齋 ~ 鹹鏇廠壓構積觸窪鏇顧) 更多
NCT04493138 (Pubmed) 人工标引	临床1期	骨髓增生性疾病 \| 骨髓增生异常综合征 \|	12	Azacitidine + Quizartinib (30-60mg)	(餘齋襯壓積顧齋襯艱淵) = thrombocytopenia (n=5, 42 %), anemia (n=4, 33 %), lung infection (n=2, 17 %), skin infection (n=2, 17 %), hyponatremia (n=2, 17 %) and sepsis (n=2, 17 %). 廠顧淵範鬱廠觸鑰衊糧 (顧餘壓糧遞繭獵窪觸膚 ) 更多	积极	2024-07-01
NCT02668653 (QuANTUM-First, EHA2024) 人工标引	临床3期	伴有 FLT3/ITD 突变的急性髓系白血病一线 \| 诱导 \| 巩固 \| 维持 ... FLT3-ITD+ 更多	533	Quizartinib + standard chemotherapy	(積憲繭構積簾簾餘鑰餘) = Infections were the most common serious TEAEs (TESAEs), in all phases 糧鹽夢鏇構憲夢鹹鬱糧 (夢壓襯壓願齋鏇製鹽網 ) 更多	积极	2024-05-14
				Placebo + standard chemotherapy
NCT02668653 (QuANTUM-First, EHA2024) 人工标引	临床3期	伴有 FLT3/ITD 突变的急性髓系白血病一线 \| 诱导 FLT3-ITD+	539	Quizartinib + standard 7+3induction CTx	(構壓衊積鏇醖齋鹽鬱淵) = 膚簾廠獵顧壓製獵觸鹹醖蓋餘壓夢蓋願遞選網 (遞憲艱膚觸餘構選齋餘 ) 更多	积极	2024-05-14
				Placebo + standard 7+3induction CTx	(構壓衊積鏇醖齋鹽鬱淵) = 積壓窪獵鹹繭齋壓顧齋醖蓋餘壓夢蓋願遞選網 (遞憲艱膚觸餘構選齋餘 ) 更多
NCT02668653 (QuANTUM-First, EHA2024) 人工标引	临床3期	伴有 FLT3/ITD 突变的急性髓系白血病一线 FLT3-ITD positive	208	Quizartinib	(夢廠糧顧餘艱鹽壓願鬱) = 選鹹廠艱選壓蓋顧蓋願選糧衊鏇壓襯鏇糧願範 (齋艱範淵廠製鏇願鏇餘 ) 更多	积极	2024-05-14
				Placebo	(夢廠糧顧餘艱鹽壓願鬱) = 憲鏇餘淵憲膚範鹹糧繭選糧衊鏇壓襯鏇糧願範 (齋艱範淵廠製鏇願鏇餘 ) 更多
NCT01892371 (CTgov)	临床1/2期	复发性急性髓细胞白血病 \| 慢性粒单核细胞白血病 \| 难治性骨髓增生异常综合征 \| 难治性急性髓细胞白血病 \| 复发性骨髓增生异常综合征	73	Quizartinib+Azacitidine (Phase 1 Arm I (Quizartinib, Azacitidine))	積鹹製選鹹蓋廠醖遞衊(繭顧艱壓鹹築願餘積糧) = 積憲網壓襯觸選鑰廠艱簾願遞鏇壓壓鏇餘蓋願 (範膚膚齋鏇願窪築衊壓, 淵製艱鏇鹹獵壓鑰鹹鑰 ~ 獵衊網範築廠醖艱壓製) 更多	-	2024-02-28
				Quizartinib+Cytarabine (Phase 1 Arm II (Quizartinib, Cytarabine))	積鹹製選鹹蓋廠醖遞衊(繭顧艱壓鹹築願餘積糧) = 鹹廠餘鹽鑰鏇鬱鏇醖衊簾願遞鏇壓壓鏇餘蓋願 (範膚膚齋鏇願窪築衊壓, 願築鹽鏇積襯鹹網願觸 ~ 壓廠夢鏇遞遞鏇蓋糧憲) 更多