预约演示
更新于：2025-01-16
Tagraxofusp-ERZS
更新于：2025-01-16
概要
基本信息
药物类型 融合蛋白 |
别名 Diphtheria toxin-il-3 fusion protein targeting IL-3 receptor、Diphtheria-toxin-interleukin-3-fusion-protein、Tagraxofusp + [8] |
靶点 |
作用机制 CD123抑制剂(白细胞介素-3受体α亚基抑制剂) |
在研适应症 |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2018-12-21), |
最高研发阶段(中国)- |
特殊审评突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (澳大利亚) |
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结构/序列
Sequence Code 453129448
来源: *****
关联
22
项与 Tagraxofusp-ERZS 相关的临床试验NCT06498973
CD123 Antibody Toxin Congregate (CD123 ATC; Tagraxofusp) Combined With Azacitidine for Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for Patients With CD123-Positive Malignant
NCT06456463
A Phase II Multicenter Open-label Trial of Tagraxofusp (Tag) in Combination With Venetoclax and Azacitidine (Ven/Aza) in Adults With Previously Untreated CD123+ Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy
NCT06561152
Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
100 项与 Tagraxofusp-ERZS 相关的临床结果
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100 项与 Tagraxofusp-ERZS 相关的转化医学
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100 项与 Tagraxofusp-ERZS 相关的专利（医药）
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130
项与 Tagraxofusp-ERZS 相关的文献（医药）2024-12-06Hematology-American Society of Hematology Education Program
BPDCN: state of the art
Review
作者: Pemmaraju, Naveen
Abstract:
The emergence of blastic plasmacytoid dendritic cell neoplasm (BPDCN) as its own distinct entity within the pantheon of hematologic malignancies is due to the growing understanding of its unique multiorgan clinical presentation and characteristic skin lesions. The occurrence of BPDCN is generally heralded by a multicompartmental presentation of violaceous cutaneous lesions, involvement by bone marrow and/or blood, lymph node invasion, and an inclination toward extramedullary organ involvement, including, most remarkably, central nervous system (CNS)/cerebrospinal fluid positivity. With a median age historically of ≥ 70 years and up to 5:1 male predominance in most of the field's earlier studies, the most notable development in the modern era is the recognition of emerging important groups with BPDCN, such as female, pediatric, and adolescent/young adult patients; CNS + BPDCN patients; and an increasing number of cases being diagnosed worldwide. These trends are in line with the increased educational and research efforts, greater international collaboration, and markedly improved diagnostic tools and clinical approaches among hematology/oncology, hematopathology, dermatology, and dermatopathology teams around the world. Now, with over 5 years since the first commercially approved targeted agent specifically dedicated for BPDCN, the CD123-targeted agent tagraxofusp, improvements have been demonstrated particularly in the frontline setting for patients with BPDCN. The field is abundant with hope, as it has experienced advancements including greater molecular characterization, expanded identification of potential targets for therapy beyond CD123, advent of combination therapies, improving parameters for stem cell transplantation, and novel clinical trials specifically available for patients with BPDCN.
2024-08-01Journal of immunotherapy and precision oncology
Overcoming Tagraxofusp-Erzs Monotherapy Resistance in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in a Real-World Clinical Setting
Article
作者: Sutamtewagul, Grerk ; Dhakal, Prajwal ; Yu, Nanmeng ; Pemmaraju, Naveen ; Sy, Mario ; Mou, Eric
ABSTRACT:
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare and clinically aggressive hematologic malignancy with limited treatment options. Currently, standard treatment strategies include clinical trials; chemotherapy regimens such as hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HCVAD); and tagraxofusp-erzs (TAG, previously SL-401) which is the first-in-class targeted therapy against CD123. TAG received Food and Drug Administration approval for frontline BPDCN treatment in December 2018 and has increasingly become an alternative to chemotherapy, offering potentially more effective and less toxic options. However, despite promising results, there are still patients who may be resistant to TAG monotherapy and/or who respond but eventually relapse. Herein, we discuss an important patient case of BPDCN treated with TAG and review BPDCN treatment strategies.
2024-07-01Cancer
Tagraxofusp, a first‐in‐class CD123‐targeted agent: Five‐year postapproval comprehensive review of the literature
Review
作者: Jen, Wei‐Ying ; Pemmaraju, Naveen ; Konopleva, Marina
Abstract:
Tagraxofusp is a first‐in‐class CD123‐directed conjugate of an amended diphtheria toxin platform and recombinant interleukin 3. Binding and subsequent internalization of the drug result in cell death via disruption of intracellular protein synthesis. CD123 is a surface marker that is expressed in several hematological malignancies, especially blastic plasmacytoid dendritic cell neoplasm (BPDCN), where its expression is ubiquitous. A pivotal study of tagraxofusp in BPDCN resulted in its approval for the treatment of BPDCN, the first treatment approved for this indication. Since the introduction of tagraxofusp, research has focused on the management of adverse effects, combination therapy to improve outcomes in fit patients, and dosing and combination strategies to mitigate toxicities while preserving efficacy, especially among older patients. The successful targeting of CD123 in BPDCN has also encouraged research into a variety of other CD123‐positive hematological neoplasms, including acute myeloid leukemia (AML), and informed the development of other novel agents targeting CD123. This review examines the clinical data leading to the development and approval of tagraxofusp in BPDCN, how it is being used in combination to improve outcomes in BPDCN and AML, and its developing role in other hematological malignancies.
58
项与 Tagraxofusp-ERZS 相关的新闻（医药）2025-01-11
·药时代
引进/卖出临床申请突破性疗法
2025-01-11
·智药邦
突破性疗法引进/卖出临床申请
2025-01-10
·美通社
100 项与 Tagraxofusp-ERZS 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Tagraxofusp-ERZS |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| Blastic浆细胞样树突状细胞肿瘤 | 美国 | 2018-12-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| CD123阳性急性髓性白血病 | 临床2期 | 美国 | 2025-01-14 | |
| CD123阳性急性髓性白血病 | 临床2期 | 澳大利亚 | 2025-01-14 | |
| CD123阳性急性髓性白血病 | 临床2期 | 韩国 | 2025-01-14 | |
| 急性髓性白血病 | 临床2期 | 美国 | 2024-05-01 | |
| 急性髓性白血病 | 临床2期 | 美国 | 2024-05-01 | |
| 淋巴母细胞淋巴瘤 | 临床2期 | 美国 | 2022-02-17 | |
| 复发性 B 细胞急性淋巴细胞白血病 | 临床2期 | 美国 | 2022-02-17 | |
| 难治性 B 细胞急性淋巴细胞白血病 | 临床2期 | 美国 | 2022-02-17 | |
| 难治性 T 急性淋巴细胞白血病 | 临床2期 | 美国 | 2022-02-17 | |
| 原发性骨髓纤维化 | 临床2期 | 意大利 | 2022-01-30 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | - | 範觸繭鬱選觸遞艱顧膚(鹽鹹選遞膚醖齋鏇築憲) = 網鑰遞窪願網範鬱襯願 鹽觸鹽鬱遞網醖鬱構蓋 (憲膚製鬱選衊蓋廠醖鬱 ) 更多 | - | 2024-12-08 | |||
N/A | CD123 | 40 | TAG 12 mcg/kg | 壓糧餘願構廠廠艱窪衊(觸鏇糧鏇觸繭鑰網繭憲) = 鏇簾範積範鹽憲淵醖構 觸獵夢鹽窪鑰範壓簾製 (選範餘構蓋鑰觸鏇範願 ) 更多 | 积极 | 2024-09-04 | |
临床1/2期 | 16 | (Stage 1: Tagraxofusp-erzs 7 µg/kg/Day) | 憲製範壓齋窪艱鏇憲構(願窪鑰網壓膚遞選繭襯) = 鬱鹽蓋鹹鹹衊顧觸窪鹽 選壓糧遞構積鏇鹽鹹憲 (憲構衊壓壓範艱蓋艱獵, 築蓋衊範膚簾繭鏇積鏇 ~ 廠醖築襯願淵築鏇鏇鬱) 更多 | - | 2024-08-21 | ||
(Stage 1: Tagraxofusp-erzs 9 µg/kg/Day) | 憲製範壓齋窪艱鏇憲構(願窪鑰網壓膚遞選繭襯) = 鬱鏇獵餘選選鹽遞衊鑰 選壓糧遞構積鏇鹽鹹憲 (憲構衊壓壓範艱蓋艱獵, 憲衊醖醖鑰廠築淵憲夢 ~ 觸網鏇網遞廠鹽繭繭膚) 更多 | ||||||
临床2期 | 3 | 衊遞網醖鹽積簾齋夢願(選艱齋顧廠製壓憲顧網) = 顧衊壓餘膚窪製鑰襯鏇 淵構鬱鬱觸鹽網繭遞範 (鹹願餘顧糧鹽鹹獵觸蓋, 構繭簾遞鏇鏇獵齋艱範 ~ 憲醖築繭衊鑰糧膚壓構) 更多 | - | 2024-07-16 | |||
N/A | Blastic浆细胞样树突状细胞肿瘤 CD123 | 18 | TAG 12 mcg/kg | 鏇觸獵醖鑰蓋觸鏇築夢(製網醖鏇鬱製鏇夢窪鏇) = 蓋鑰鬱襯鑰壓蓋築觸淵 壓繭遞簾築範鬱網網憲 (壓醖築鑰鑰選鹹壓醖選 ) 更多 | 积极 | 2024-05-14 | |
临床1期 | 56 | 選鬱獵膚構糧鹽醖遞顧(製顧鬱獵蓋顧憲襯願淵) = 鹹憲築繭壓鹹選觸網網 範鏇鬱蓋襯觸蓋襯顧網 (蓋鏇鏇憲壓願艱鏇製鏇 ) 更多 | 积极 | 2024-02-13 | |||
(expansion cohort) | 選鬱獵膚構糧鹽醖遞顧(製顧鬱獵蓋顧憲襯願淵) = 鹽衊襯網艱繭艱廠壓鹹 範鏇鬱蓋襯觸蓋襯顧網 (蓋鏇鏇憲壓願艱鏇製鏇 ) 更多 | ||||||
临床1期 | 26 | 窪醖獵簾夢蓋齋餘顧製(衊繭顧齋窪築鏇願鑰鏇) = 膚醖範鬱廠鹽鑰選構網 淵繭鏇餘鹹鑰鏇窪糧獵 (夢觸艱築遞鑰憲範範網, 14.0 ~ NA) 更多 | - | 2023-12-11 | |||
廠壓鏇選鬱獵範觸築鬱(憲壓構網網鹽夢餘艱積) = 齋鑰獵築糧鬱鹽醖衊鹽 糧製壓蓋選製顧積餘獵 (鹹鑰鏇鬱顧窪憲壓鏇選 ) | |||||||
N/A | 22 | 製構範簾艱夢繭願鹽淵(壓簾範齋淵築蓋糧餘顧) = 醖遞艱鏇選糧獵艱選築 蓋遞鏇遞醖壓鹽築襯窪 (齋構壓簾鏇壓夢築糧網, 10 ~ NR) 更多 | - | 2023-12-10 | |||
临床2期 | 23 | 艱獵範壓鑰廠壓醖鬱構(糧遞膚築憲顧齋積膚觸) = 1 patient receiving 4 courses achieved PR and died due to CNS bleeding 願積遞淵鑰鬱範淵鬱獵 (構鏇範製網餘網憲憲積 ) 更多 | - | 2023-12-10 |
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