奎扎替尼(Quizartinib Hydrochloride) - 药物靶点：FLT3_在研适应症：肿瘤，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

Quizartinib、AC-010220、AC-220

+ [7]

靶点

FLT3

作用方式

抑制剂

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

肿瘤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+ [6]

原研机构

Ambit Biosciences Corp.

在研机构

Daiichi Sankyo Europe GmbH

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo UK Ltd.

+ [3]

非在研机构

Ambit Biosciences Corp.

Anderson University

富启睿医药研发（北京）有限公司

权益机构

Daiichi Sankyo Co., Ltd.Genesis Pharmaceuticals Ltd.

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)申请上市

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

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结构/序列

分子式C29H34Cl2N6O4S

InChIKeyDHYPGRVMIOATAE-UHFFFAOYSA-N

CAS号1132827-21-4

关联

49

项与奎扎替尼相关的临床试验

CTIS2025-522979-29-00

/ Not yet recruiting临床3期IIT

A randomized phase III, global, multicentre, open label clinical trial comparing Venetoclax Azacitidine and Quizartinib vs Venetoclax and Azacitidine in newly diagnosed acute myeloid leukemia patient´s ineligible for standard induction chemotherapy.

开始日期2026-03-23

申办/合作机构-

CTIS2024-512503-39-00

/ Recruiting临床4期

MRD registry and multicenter, randomized controlled pragmatic trial of standard intensity versus reduced intensity consolidation treatment in MRD-negative patients with AML or CLL (RESOLVE trial).

开始日期2025-12-19

申办/合作机构-

NCT06824168

/ Recruiting临床2期

A Phase 2, Multicenter, Randomized, Open-label Trial to Evaluate Safety and Efficacy of Two Dose Levels of Quizartinib as Maintenance for Adult Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia in Complete Remission

This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

开始日期2025-07-18

申办/合作机构

Daiichi Sankyo Co., Ltd.

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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335

项与奎扎替尼相关的文献（医药）

2026-01-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

3H-pyrazolo[4,3-f]quinoline hinge binder, a tunable scaffold for development of novel kinase inhibitors against FLT3-driven leukemia

Article

作者: Sintim, Herman O ; Dayal, Neetu ; Hernandez, Delmis E ; Hunjan, Mandeep Kaur ; Bělíček, Jakub ; Peřina, Miroslav ; Jorda, Radek ; Řezníčková, Eva ; Brauer, Nickolas R ; Krňávková, Petra ; Yadav, Pratik ; Vojáčková, Veronika ; Bařina, Marek

The 3H-pyrazolo[4,3-f]quinoline moiety, synthesized via a Doebner or Povarov multi-component reaction, has been described as an innovative scaffold capable of interacting with the hinge region of several protein kinases, including FLT3. The receptor tyrosine kinase FLT3 and its oncogenic variants, such as ITD or D835Y, has been validated as a therapeutic target for the therapy of acute myelogenous leukemia. In this study, we demonstrate that the substitution pattern of the phenyl group at the 7-posititon of 3H-pyrazolo[4,3-f]quinoline has an impact on FLT3 kinase inhibition. Out of 48 synthesized compounds, we present here HSB401, which showed nanomolar inhibitory activities against recombinant FLT3-ITD, FLT-ITD-F691L and D835Y mutants and FLT3-driven cancer cell lines MOLM-13 and MV4-11, as well as Ba/F3 cells associated with the FLT3-ITD mutation. Approved FLT3 inhibitor quizartinib strongly inhibits both FLT3 and c-KIT, resulting in significant myelosuppression. Notably, the lead compound HSB401 inhibits c-KIT with approximately 100-fold lower potency compared to FLT3-D835Y. This suggests that HSB401 may spare normal hematopoiesis and mitigate the risk of myelosuppression. Mechanistic studies in MV4-11 cells revealed downregulated FLT3 signaling after 2 h of treatment with HSB401 and cell cycle arrest and apoptosis in the prolonged experiment. In addition, oral administration of HSB401 significantly suppressed tumor growth in the MV4-11 xenograft mouse model.

2026-01-01·JOURNAL OF CLINICAL ONCOLOGY

Quizartinib for Newly Diagnosed FLT3 -Internal Tandem Duplication–Negative AML: The Randomized, Double-Blind, Placebo-Controlled, Phase II QUIWI Study

Article

作者: Bernal, Teresa ; López-Lorenzo, Jose Luis ; Tormo, Mar ; Calbacho, Maria ; Bergua, Juan Miguel ; Algarra Algarra, Jesús Lorenzo ; Labrador, Jorge ; Romero Aguilar, Antonio ; Vidriales, Maria-Belén ; Vives, Susana ; Colorado, Mercedes ; Sánchez-Vadillo, Irene ; Raposo-Puglia, José Ángel ; Alonso, Natalia ; Olivares, Matxalen ; Ayala, Rosa ; Martínez-Francés, Antonio ; Olave, María Teresa ; Paiva, Bruno ; Calbacho, María ; Calasanz, Maria José ; Martínez-Cuadrón, David ; Rodríguez-Arbolí, Eduardo ; Pérez Simón, José Antonio ; García Pérez, María José ; Arce, Olga ; Fernández Fernández, Alfonso ; López-López, Juan Antonio ; Rodríguez-Veiga, Rebeca ; Fernández, Alfonso ; Serrano, Josefina ; Khoroz, Iryna Luts ; González, Bernardo Javier ; Amador Barciela, María Lourdes ; Gómez Roncero, María Isabel ; Sayas, Maria José ; Cuevas, Laida ; Cepillo, Inmaculada Marchante ; Casas-Avilés, Ignacio ; Lloret-Madrid, Pilar ; Rodríguez-Medina, Carlos ; Sánchez, Maria-José ; Cuello, Rebeca ; Jose Sayas, Maria ; Barragán, Eva ; Solé Rodríguez, María ; Sánchez, María-José ; Cuevas Palomares, Laida ; Noriega, Víctor ; Olave, Maria Teresa ; García Boyero, Raimundo ; Mateos, M. Carmen ; Polo, Marta ; López Lorenzo, José Luis ; Noriega, Victor ; Herrera Puente, Pilar ; Botella, Carmen ; Boluda, Blanca ; Barrios, Manuel ; Gómez-Roncero, Maria Isabel ; Salamero, Olga ; Suárez, Sandra ; Rodríguez, María Solé ; Mosquera, Adrian ; Montesinos, Pau ; Chillón, Carmen ; Martínez-Chamorro, Carmen

PURPOSE:

Quizartinib, an oral, selective, second-generation, type-II FMS-like tyrosine kinase 3 (FLT3) inhibitor with high binding affinity to internal tandem duplication (ITD) and wild-type (WT) FLT3, has shown early clinical activity as monotherapy in patients with relapsed/refractory FLT3 -ITD–negative AML. The phase III QuANTUM-First trial showed that quizartinib significantly prolonged survival versus placebo when added to standard chemotherapy, followed by single-agent maintenance, in patients with newly diagnosed (ND) FLT3- ITD–positive AML. We investigated the safety and efficacy of quizartinib in patients with ND FLT3 -ITD–negative AML.

METHODS:

The phase II, randomized, double-blind, placebo-controlled QUIWI trial enrolled patients age 18-70 years with ND FLT3 -ITD–negative (mutant-to-WT allelic ratio <0.03) AML. Patients were randomly assigned 2:1 to receive standard induction and consolidation chemotherapy combined with either quizartinib 60 mg once daily or placebo, followed by single-agent maintenance with quizartinib or placebo. The primary end point was event-free survival (EFS). Secondary end points included overall survival (OS) and safety.

RESULTS:

Overall, 273 patients were randomly assigned to quizartinib (n = 180) or placebo (n = 93). At data cutoff, median EFS was 20.4 months and 9.9 months in the quizartinib and placebo arms, respectively ( P = .046). Median OS was not reached and 29.3 months in the quizartinib and placebo arms, respectively ( P = .012); 3-year OS rates were 60.8% and 45.7%. The most frequently reported adverse events (any grade) were fever, rash, diarrhea, and mucositis.

CONCLUSION:

The addition of quizartinib to standard chemotherapy was associated with significantly longer EFS and OS than placebo in patients with ND FLT3 -ITD–negative AML.

2026-01-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Rational design of next-generation FLT3 inhibitors in acute myeloid leukemia: From laboratory to clinics

Review

作者: Gao, Shan ; Wang, Xueting ; Zhao, Xiang ; Xiao, Zhennan

Activating mutations of FMS-like tyrosine kinase-3 (FLT3) are among the most common genetic alterations in acute myeloid leukemia (AML), affecting approximately 30 % of patients and leading to a poor prognosis. The development of FLT3-targeted inhibitors has achieved significant progress. First-generation multi-kinase inhibitors like midostaurin and second-generation agents such as gilteritinib and quizartinib have shown success. However, drug resistance, often due to D835Y and F691L gatekeeper mutations, remains a major challenge. In response, a new generation of FLT3 inhibitors (FLT3i) have been designed to simultaneously target both FLT3 internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations. This review examines the mechanisms of FLT3 in the regulation of AML and examines preclinical research on novel FLT3i over the past five years. It discusses how these agents, including small-molecule like STI-8591, compounds 36 and 80 and novel therapeutic strategies such as CLN-049, and SENTI-202, are designed to combat resistance. The goal is to provide a medicinal chemistry perspective to provide insights for the design of novel small-molecule FLT3i.

176

项与奎扎替尼相关的新闻（医药）

2026-01-08

·Pharma信息差

【2026年1月8日全球药闻】

1. 葛兰素史克"功能性治愈"肝炎B疗法在III期试验中证明价值，为审批铺平道路葛兰素史克潜在的肝炎B"功能性治愈"药物在两项备受期待的III期研究中证明其价值，为向美国FDA提交审批申请奠定基础。 2. 安进与Disco达成6.18亿美元癌症靶点合作，聚焦新治疗靶点安进与德国生物技术公司Disco Pharmaceuticals达成价值6.18亿美元的合作协议，委托该机构针对其已识别的癌症治疗靶点开发疗法。 3. Soley Therapeutics获2亿美元C轮融资，推进AML细胞应激药物进入临床人工智能生物技术公司Soley Therapeutics获得2亿美元C轮融资，计划用于将其主导的急性髓系白血病资产推进至临床试验阶段。 4. 乐天医疗新增1亿美元融资，瞄准2028年向美国FDA提交申请乐天医疗再次完成大规模融资，获得1亿美元资金，推动其主导的光动力癌症疗法向2028年目标FDA审批申请迈进。 5. Pulmocide终止III期抗真菌试验，因反应率低和死亡率较高 Pulmocide的III期试验因接受其研究性吸入抗真菌药的患者反应率较低且死亡风险高于对照组患者而终止。 6. 和黄医药热推自身免疫竞赛，III期成功为中国申报铺路和黄医药自身免疫疾病候选药物sovleplenib的III期试验达到主要终点，为在中国提交申请注入动力。 7. 基立福授权Genesis在13个欧洲国家商业化白血病药物Vanflyta 根据协议，Genesis负责在13个欧洲国家销售第一三共2023年获批的急性髓系白血病药物Vanflyta（通用名：quizartinib）。 8. 美国FDA未标题信函批评Esperion关于降胆固醇药Nexlizet的电视广告声称美国FDA对Esperion Therapeutics降胆固醇药物Nexlizet（通用名：bempedoic acid）电视广告中"脂质潜伏者"相关声明提出质疑。 9. 生物技术并购市场2025年交易额达1140亿美元，显示行业复苏迹象尽管面临地缘政治和监管动荡，2025年生物制药行业并购活动活跃，总交易额超过1140亿美元，较2024年翻倍增长。 10. 美国海关与边境保护局将停止纸质退税，转向数字化处理随着进口商等待最高法院关于行政关税权力的裁决，美国海关与边境保护局将逐步转向数字化退税处理系统。信源整合 BioPharma Dive | MedTech Dive | Fierce Biotech | Fierce Pharma | PharmaVoice | Healthcare Dive | SupplyChain Dive | Manufacturing Dive

临床3期临床成功

2026-01-07

·BioSpace

Daiichi Sankyo and GENESIS Pharma Enter Exclusive Agreement for VANFLYTA® Commercialization in Central and Eastern Europe

Exclusive agreement covers 13 Central and Eastern European markets Collaboration will help expand access to VANFLYTA for patients with newly diagnosed FLT3 -ITD positive AML MUNICH--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and GENESIS Pharma have entered into an exclusive license and supply agreement for the distribution and commercialization of VANFLYTA ® (quizartinib) in 13 markets across Central and Eastern Europe for the treatment of adult patients with newly diagnosed FLT3 -ITD positive acute myeloid leukemia (AML). Under the terms of the agreement, Daiichi Sankyo will be responsible for the manufacturing and supply of VANFLYTA while GENESIS Pharma will lead medical affairs, market access and commercialization efforts in Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia. Financial terms of the agreement are not being disclosed. VANFLYTA was approved in the EU in November 2023 for the treatment of adult patients with newly diagnosed FLT3 -ITD positive AML in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation, based on the results from the QuANTUM-First trial. “This agreement with GENESIS Pharma represents an important step in our ambition to expand access to our innovative targeted medicine across Central and Eastern Europe,” said Markus Kosch, MD, Head, Oncology Business Division Europe and Canada, Daiichi Sankyo. “By combining our scientific expertise with the strong regional footprint of GENESIS Pharma, we aim to accelerate access to VANFLYTA for patients with newly-diagnosed FLT3 -ITD positive AML and ultimately help improve outcomes in this high-risk population.” “This new strategic collaboration marks another significant milestone for our company, reinforcing our long-standing expertise and focus on advancing medicines for difficult-to-treat cancers,” said Constantinos Evripides, Managing Director, GENESIS Pharma. “Daiichi Sankyo has entrusted us with a broad territory across Central and Eastern Europe and we look forward to working together to accelerate access to VANFLYTA across the region.” About FLT3 -ITD Positive Acute Myeloid Leukemia Almost 487,300 new cases of leukemia were reported globally in 2022, with more than 305,400 deaths. 1 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults. 2,3 In Europe, approximately 18,000 people are diagnosed with AML each year and the five-year survival rate is reported at 17% for adult patients. 4,5 A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common. 6 Approximately 80% of FLT3 mutations are FLT3 -ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis including increased risk of relapse and shorter overall survival. 7,8 FLT3 -ITD mutations occur in about 25-30% of all adult patients suffering from AML. 7,8 About VANFLYTA VANFLYTA is an oral, highly potent and selective type II FLT3 inhibitor approved in more than 30 countries/regions in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation, for the treatment of adult patients with newly diagnosed AML that is FLT3 -ITD positive based on the results from the QuANTUM-First trial. In the U.S., VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated. In Japan, VANFLYTA is also approved for the treatment of patients with relapsed/refractory AML that is FLT3 -ITD mutation positive, as detected by an approved test, based on results from the QuANTUM-R trial. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit . About GENESIS Pharma GENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies. For more information, please visit and follow us on LinkedIn . References: 1 Global Cancer Observatory. Population Fact Sheet : World. Updated February 2024. 2 American Cancer Society: Key Statistics for Acute Myeloid Leukemia . Updated January 2023 3 Dong Y, et al. Exp Hematol Oncol . (2020);9:14. 4 Rodriguez-Abreu D, et al. Ann Oncol . (2007);18 Suppl 1:i3-i8 5 Heuser M, et al. Ann Oncol . (2020) 31(6):697-712. 6 Kennedy VE, et al. Front Onc. 23 December 2020;10. Volume 10 – 2020 7 Daver N, et al. Leukemia . (2019) 33:299-312. 8 Patel JP, et al N Engl J Med . (2012) Mar 22;366(12):1079-89. Contacts Media: Simone Jendsch-Dowé Daiichi Sankyo Europe GmbH Simone.Jendsch-Dowe@daiichisankyo.com +49 (89) 78080 (office) Natalia Karahaliou GENESIS Pharma nkarahaliou@genesispharma.com +30 210 87 71 605

引进/卖出上市批准临床结果

2025-12-29

·ioncology

全球创新药物奎扎替尼正式落地瑞金海南医院，依托“特许药械”政策精准惠及国内AML患者

点击蓝字关注我们近日，全球创新靶向药物盐酸奎扎替尼片在我国瑞金海南医院正式实现临床可及，这一突破性进展为我国FLT3-ITD突变阳性急性髓系白血病（AML）患者带来了全新治疗选择。作为一款高选择性FLT3抑制剂，奎扎替尼已率先在美国、欧洲、日本等多国获批上市，此次落地博鳌乐城先行区标志着我国该类AML患者无需远赴海外，即可同步享受到全球先进的精准治疗方案。依托博鳌“零关税”进口药械政策红利，这款重磅药物的落地，不仅丰富了国内AML精准治疗的药物梯队，更彰显了我国在恶性血液肿瘤治疗领域与国际接轨的步伐加速。盐酸奎扎替尼片17.7 mg/片盐酸奎扎替尼片26.5 mg/片治疗困境 FLT3突变成AML领域核心挑战急性髓系白血病（AML）是一种来源于造血干细胞的血液系统恶性疾病，以髓系来源的异常分化原始细胞克隆性扩增为特征，年龄<60岁的患者长期生存率为35%～45%，年龄≥60岁的患者长期生存率仅为10%～15%1。 FMS样酪氨酸激酶3（FLT3）是正常造血过程的关键调控因子，在造血干细胞和祖细胞中高表达。除在干细胞存活与增殖中发挥作用外，FLT3信号传导对于免疫调节也至关重要，尤其是树突状细胞分化和自然杀伤（NK）细胞扩增。在AML中，FLT3突变是最常见的基因改变类型之一，包括内部串联重复（FLT3-ITD）和酪氨酸激酶结构域（FLT3-TKD）替换突变，这些突变会驱动增殖和抗凋亡通路的组成性激活，并导致不良预后2。奎扎替尼作为强效且具有选择性的FLT3抑制剂显著改变了临床治疗结局，重塑了FLT3突变型AML的治疗模式，使这一历史上高风险的患者亚群转变为具有长期生存现实前景的群体。核心数据 QuANTUM-First试验奠定应用基石奎扎替尼的临床价值已得到全球多中心III期临床试验QuANTUM-First的充分验证，该研究结果已发表于权威医学期刊《The Lancet》，为其全球获批及临床应用提供了坚实依据3。 QuANTUM-First是一项随机双盲、安慰剂对照的全球性研究，纳入新确诊的FLT3-ITD阳性AML患者，按1:1随机分配至奎扎替尼组或安慰剂组。患者分别接受奎扎替尼或安慰剂联合标准化疗的诱导、巩固治疗，后续再接受对应药物单药维持治疗3年。研究主要终点总生存期（OS）数据显示，中位随访39.2个月时，奎扎替尼组中位OS达31.9个月（95%CI：21.0~26.2），显著优于安慰剂组的15.1个月（95%CI：13.2~26.2），风险比（HR）为0.78（95%CI：0.62~0.98，P=0.032），意味着奎扎替尼联合治疗可显著降低患者死亡风险22%。在缓解深度与持续时间方面，尽管两组完全缓解（CR）率相近，但奎扎替尼组中位缓解持续时间（DoR）达38.6个月，较安慰剂组的12.4个月延长3倍以上，提示患者可获得更持久的疾病控制。 QuANTUM-First研究中ITT人群的OS结果值得关注的是，近年来，FLT3-ITD微小残留病（MRD）逐渐成为预测疾病复发和生存的关键指标。最新研究证实4，奎扎替尼可有效降低患者MRD水平，且这一降低与生存获益直接相关。此外，即便对于预后更差的长FLT3-ITD突变患者，奎扎替尼的疗效仍不受影响，同时其疗效也不受NPM1共突变状态影响，表明该药物适用人群广泛，可为不同分子特征的FLT3-ITD突变AML患者带来获益。除广受关注的QuANTUM-First研究外，另一项奎扎替尼的国际多中心Ⅲ期临床研究——QuANTUM-Wild研究也正在紧锣密鼓地推进当中。该研究旨在进一步挖掘奎扎替尼在新诊断的FLT3-ITD阴性AML成人患者中的潜在应用价值。若取得积极成果，意味着奎扎替尼的治疗边界有望进一步拓展，从而为更广泛的AML患者群体带来新的精准治疗选择。安全可控耐受性良好契合临床治疗需求 QuANTUM-First试验的安全性数据显示3，奎扎替尼组与安慰剂组的不良事件发生率相近，未出现新的安全性信号。其中，奎扎替尼组100%（264/265例）的患者发生至少1起不良事件，安慰剂组为99%（265/268例）；≥3级不良事件发生率分别为92%（244/265例）和90%（240/268例）。两组最常见的3/4级不良事件均为发热性中性粒细胞减少、低钾血症和肺炎，均为AML化疗相关的常见不良事件，临床可通过常规干预手段有效管理。这一安全性特征表明，奎扎替尼治疗方案总体耐受性良好，契合临床长期治疗需求，为患者安全用药提供了有力保障。政策赋能落地博鳌精准惠及国内患者中国国家药监局药品审评中心（CDE）官网 2025年1月18日，第一三共（Daiichi Sankyo）申报的5.1类新药盐酸奎扎替尼片上市申请已获中国国家药监局药品审评中心（CDE）受理5。此次依托博鳌乐城“特许药械”政策优势，该药物将率先在瑞金海南医院实现临床可及，彻底解决了以往国内患者需远赴海外寻求先进治疗方案的困境。作为连接国际先进药械与国内患者需求的“桥头堡”，博鳌乐城通过保税药仓等制度创新，将实现特许药械从入库到病房的快速调拨，极大缩短了患者用药的等待时间。此次盐酸奎扎替尼片的落地，不仅为临床医生治疗FLT3-ITD突变阳性AML患者提供了全新的精准治疗工具，更丰富了国内AML精准治疗的药物梯队，推动我国AML治疗从“广谱化疗”向“精准靶向”的进阶再提速。总结盐酸奎扎替尼片在瑞金海南医院的正式可及，是我国恶性血液肿瘤治疗领域与国际接轨的重要里程碑。依托QuANTUM-First试验证实的显著获益与良好安全性，该药物将为国内FLT3-ITD突变阳性AML患者带来更长生存期、更持久缓解的治疗希望。同时，本次引进也彰显了博鳌“乐城政策”在加速全球创新药械落地、保障患者用药权益方面的重要价值，为后续更多恶性肿瘤创新药物的快速引进提供了可借鉴的范例。展望未来，随着该药物在中国正式获批进程的推进，结合在临床中的持续应用与探索，必将进一步优化我国AML的整体治疗格局，助力实现“健康中国”战略下提升患者生存质量与生存期的长远目标。温馨提示有治疗需求的患者，可通过登录“瑞金海南医院特许药械医患管理平台”小程序，在线完成病情预评估，初步明确是否符合用药方向。在瑞金海南医院线下门诊，经专科医生详细评估、判断符合用药指征后，即可在院内规范接受盐酸奎扎替尼片治疗。预评估操作流程 1 长按识别，进入瑞金海南医院特许药械医患管理平台小程序； 2 搜索栏搜索盐酸奎扎替尼片； 3 点击进入盐酸奎扎替尼片页面； 4 点击申请预评估； 5 选择评估专家-添加需要评估的就诊人-添加就诊人的病历，完成后点击立即申请。参考文献：（上下滑动查看更多） 1.急性髓系白血病微小残留病检测与临床解读中国专家共识（2021年版）.中华血液学杂志, 2021,42(11) : 889-897. 2.Stancioaica MC, Coriu D, Ghiaur G. FLT3: A 35-Year Voyage from Discovery to the Next Generation of Targeted Therapy in AML. Cancers (Basel). 2025 Oct 23;17(21):3415. 3.Erba HP, Montesinos P, Kim HJ, Patkowska E, Vrhovac R, Žák P, Wang PN, Mitov T, Hanyok J, Kamel YM, Rohrbach JEC, Liu L, Benzohra A, Lesegretain A, Cortes J, Perl AE, Sekeres MA, Dombret H, Amadori S, Wang J, Levis MJ, Schlenk RF; QuANTUM-First Study Group. 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 May 13;401(10388):1571-1583. 4.Levis MJ, Erba HP, Montesinos P, Kim HJ, Vrhovac R, Patkowska E, Zak P, Wang PN, Connolly Rohrbach JE PhD, Chang K, Liu L, Mostafa Kamel Y, Imadalou K, Lesegretain A, Cortes JE, Sekeres MA, Dombret H, Amadori S, Wang J, Schlenk RF, Perl AE. FLT3-ITD measurable residual disease from the QuANTUM-First trial. Blood Adv. 2025 Oct 6:bloodadvances.2025016444. 5.中国国家药监局药品审评中心官网. （来源：《肿瘤瞭望–血液时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

上市批准临床3期临床结果临床2期

100 项与奎扎替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	奎扎替尼	L01XE52	DB12874

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肿瘤	加拿大	第一三共制药（上海）有限公司	2025-05-01
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3期	美国	Daiichi Sankyo Co., Ltd.	2014-05-01
FLT3阳性急性髓性白血病	临床3期	澳大利亚	Daiichi Sankyo Co., Ltd.	2014-05-01
FLT3阳性急性髓性白血病	临床3期	比利时	Daiichi Sankyo Co., Ltd.	2014-05-01
FLT3阳性急性髓性白血病	临床3期	加拿大	Daiichi Sankyo Co., Ltd.	2014-05-01
FLT3阳性急性髓性白血病	临床3期	克罗地亚	Daiichi Sankyo Co., Ltd.	2014-05-01
FLT3阳性急性髓性白血病	临床3期	捷克	Daiichi Sankyo Co., Ltd.	2014-05-01
FLT3阳性急性髓性白血病	临床3期	法国	Daiichi Sankyo Co., Ltd.	2014-05-01
FLT3阳性急性髓性白血病	临床3期	德国	Daiichi Sankyo Co., Ltd.	2014-05-01
FLT3阳性急性髓性白血病	临床3期	中国香港	Daiichi Sankyo Co., Ltd.	2014-05-01
FLT3阳性急性髓性白血病	临床3期	匈牙利	Daiichi Sankyo Co., Ltd.	2014-05-01

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临床结果

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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, ASH2025)	临床3期	伴有 FLT3/ITD 突变的急性髓系白血病一线 FLT3-ITD+	533	Quizartinib+chemotherapy	憲襯襯衊膚構壓鑰構製(簾鹹鬱鹽構壓艱鬱襯觸) = 選顧獵憲構廠製製窪選構壓膚衊醖醖艱鑰顧顧 (壓壓簾醖築夢構鬱蓋築, 26.1 ~ 32.4) 更多	积极	2025-12-06
				Placebo+chemotherapy	憲襯襯衊膚構壓鑰構製(簾鹹鬱鹽構壓艱鬱襯觸) = 鑰窪夢廠壓鏇築蓋齋顧構壓膚衊醖醖艱鑰顧顧 (壓壓簾醖築夢構鬱蓋築, 19.8 ~ 25.6) 更多
NCT02668653 (QuANTUM-First, EHA2025)	临床3期	伴有 FLT3/ITD 突变的急性髓系白血病 FLT3-ITD \| NPM1 \| DNMT3A ... 更多	518	Quizartinib	齋繭鏇蓋遞餘廠壓簾蓋(餘衊窪鹽築壓鏇構壓鬱) = 鑰製衊衊壓積簾願窪遞選獵遞簾簾鑰築餘積繭 (築網範築鏇築衊鹹膚齋 )	积极	2025-05-14
				Placebo	齋繭鏇蓋遞餘廠壓簾蓋(餘衊窪鹽築壓鏇構壓鬱) = 鬱觸觸鏇繭製艱構襯窪選獵遞簾簾鑰築餘積繭 (築網範築鏇築衊鹹膚齋 )
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	糧膚鹽鹽繭鬱觸襯醖製(淵網積餘餘夢糧願顧襯) = 餘構築顧製齋壓鏇鑰醖顧觸鑰鏇鏇構艱網遞夢 (獵糧構糧獵糧糧鹽淵願 ) 更多	积极	2024-12-09
				Placebo	糧膚鹽鹽繭鬱觸襯醖製(淵網積餘餘夢糧願顧襯) = 繭廠艱餘觸窪觸淵窪遞顧觸鑰鏇鏇構艱網遞夢 (獵糧構糧獵糧糧鹽淵願 ) 更多
ASH2024	N/A	伴有 FLT3/ITD 突变的急性髓系白血病	-	Quizartinib	繭艱簾獵簾衊窪膚鏇膚(憲壓遞艱積顧艱遞鏇夢) = 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. 顧壓鹹鹽鹹廠獵觸淵構 (構廠淵簾齋壓繭糧齋壓 )	-	2024-12-09
				Venetoclax
ASH2024	N/A	FLT3阳性急性髓性白血病	-	Quizartinib	齋築襯網襯齋鹽醖鹹壓(繭膚窪夢鏇觸積壓醖選) = 範淵廠鑰鹹獵蓋獵顧構繭顧衊襯醖願製憲構簾 (積齋鏇夢願範遞製鑰顧 ) 更多	-	2024-12-08
				Placebo	齋築襯網襯齋鹽醖鹹壓(繭膚窪夢鏇觸積壓醖選) = 壓獵鹹夢築鬱鹹蓋廠製繭顧衊襯醖願製憲構簾 (積齋鏇夢願範遞製鑰顧 ) 更多
NCT04107727 (QUIWI, ASH2024) 人工标引	临床2期	急性髓性白血病一线 FLT3-ITD negative	273	Quizartinib	膚構顧窪網鹽鹽範鏇顧(齋鏇窪膚構蓋淵窪築艱) = 製築鏇遞齋廠襯膚遞憲襯製衊膚齋繭襯願鹹網 (膚鹽淵獵衊糧願範襯襯 ) 更多	积极	2024-12-07
				Placebo	膚構顧窪網鹽鹽範鏇顧(齋鏇窪膚構蓋淵窪築艱) = 襯選膚壓廠餘齋鹹網鬱襯製衊膚齋繭襯願鹹網 (膚鹽淵獵衊糧願範襯襯 ) 更多
NCT03135054 (ASH2024)	临床2期	急性髓性白血病 FLT3-ITD突变	40	高三尖杉酯碱+奎扎替尼高三尖杉酯碱+奎扎替尼	鹽夢襯築鹽選網憲繭選(遞廠窪遞鹽齋獵遞憲糧) = 遞衊願網簾選鏇鏇繭鏇醖糧繭蓋鑰選獵餘觸積 (膚淵鑰繭鹹餘憲鹹淵繭 ) 更多	积极	2024-12-07
QuANTUM-First Trial (SOHO2024)	临床3期	FLT3-ITD+	539	Quizartinib	蓋鑰繭鑰窪淵襯鏇製觸(衊襯簾襯齋鑰襯觸獵憲) = 蓋範鹽製簾構壓醖觸夢窪糧製鏇顧鏇選齋築築 (糧鑰齋築鑰遞蓋淵繭鹹 )	积极	2024-09-04
				Placebo	蓋鑰繭鑰窪淵襯鏇製觸(衊襯簾襯齋鑰襯觸獵憲) = 憲繭獵獵範簾鑰鏇淵鹹窪糧製鏇顧鏇選齋築築 (糧鑰齋築鑰遞蓋淵繭鹹 )
NCT02668653 (QuANTUM-First, SOHO2024)	临床3期	急性髓性白血病 FLT3-ITD+	539	Quizartinib 40 mg/d	夢齋鹹觸糧餘壓夢構膚(願憲衊襯艱鑰獵憲餘襯) = Primary EFS analysis (42d from last induction cycle used to define induction treatment failure [ITF]) did not differ between treatment arms by age 醖觸觸憲積夢醖觸鑰獵 (積願鏇繭艱糧鑰壓鏇鹽 ) 更多	积极	2024-09-04
				Placebo
NCT04493138 (Phase 1 study of azacitidine in combination with quizartinib in patients with FLT3 or CBL mutated MDS and MDS/MPN, Pubmed \| Leuk Res) 人工标引	临床1期	骨髓增生性疾病 \| 骨髓增生异常综合征 CBL Mutation \| FLT3 Mutation	12	Azacitidine + Quizartinib 30mg	襯構衊淵餘顧願膚憲鹹(淵築鑰遞醖淵製簾憲鬱) = 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 %). 餘艱鏇簾廠壓構鹹淵衊 (膚艱網築顧鹽蓋糧壓積 ) 更多	积极	2024-07-01