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更新于：2026-02-03
Naxitamab
那昔妥单抗
更新于：2026-02-03
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2020-11-25), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)、罕见儿科疾病 (美国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 15562688L
来源: *****
Sequence Code 319373165H
来源: *****
关联
21
项与 那昔妥单抗 相关的临床试验NCT07011654
Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
NCT07027748
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
NCT06540963
Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
100 项与 那昔妥单抗 相关的临床结果
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100 项与 那昔妥单抗 相关的转化医学
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100 项与 那昔妥单抗 相关的专利（医药）
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125
项与 那昔妥单抗 相关的文献（医药）2025-10-01JOURNAL OF PEDIATRIC HEMATOLOGY ONCOLOGY
Naxitamab-combination Therapy for the Treatment of Patients With Refractory and/or Relapsed High-risk Neuroblastoma
Article
作者: Michael, Meghan ; Saulnier-Sholler, Giselle ; Oesterheld, Javier ; Brown, Lauren ; Trovillion, Erin Murphy ; Phillips, Katlin
Approved treatments for patients with refractory and/or relapsed (R/R) high-risk (HR) neuroblastoma are limited, and there is a need for new treatment combinations. In this case series, 4 patients were treated with the anti-GD2 monoclonal antibody naxitamab and granulocyte-macrophage colony-stimulating factor (GM-CSF) in combination with cyclophosphamide and topotecan between August 2021 and December 2022. This combined chemoimmunotherapy regimen was well tolerated in these heavily pretreated patients with R/R HR neuroblastoma who had few treatment options and overall poor prognoses.
2025-09-01CHILD CARE HEALTH AND DEVELOPMENT
The Psychological Experience of Caregivers of Children With Neuroblastoma Undergoing Naxitamab Treatment: A Qualitative Study in China
Article
作者: Lichun Fan ; Yunfei Chen ; Wenjing Liang ; Xiaohua Li ; Ziling Ji ; Xiao Wang ; Xiaojing Hu ; Yan Xuan
ABSTRACT:
Background:
Neuroblastoma (NB) is a prevalent malignant tumour affecting children. Due to its insidious onset, malignant nature and poor prognosis, the absence of effective treatments presents a significant challenge, profoundly impacting children and their families. Children embody the core and hope of a family, and when faced with sudden adversity, parents often undergo psychological crises marked by anxiety, depression and severe emotional distress. Fortunately, XXX Hospital serves as a testing ground for novel domestic medications, offering not only therapy but also instilling hope in children with NB and their families. Among these medications, naxitamab (hu3F8) has shown promising efficacy in treating NB. This qualitative study aims to investigate the psychological experiences of caregivers of children with NB undergoing naxitamab treatment at a hospital in China, a specialized institution. Subsequently, tailored psychological support for caregivers will be considered based on the findings.
Method:
Employing phenomenological research techniques, we conducted face‐to‐face semistructured interviews with 14 caregivers of children diagnosed with NB. Colaizzi's seven‐step analysis method was employed to analyse the interview data.
Results:
The psychological experiences of caregivers of children with NB were categorized into three main themes and 11 subthemes: the pretreatment stage (challenges during diagnosis, shock and collapse upon diagnosis and persistent pursuit of hope); the in‐treatment stage (treatment‐related worries and fears, significant financial strain, renewed hope and expectations during treatment and reliance on medical staff for trust and hope); and the posttreatment stage (changes in perspectives following treatment, rethinking expectations for children, anticipating the development of novel therapeutic agents and expectations regarding financial support).
Conclusion:
Caregivers of children undergoing naxitamab treatment for NB encounter diverse psychological challenges throughout different stages. It is crucial for clinical medical professionals to provide tailored psychological support to both children and their families during various stages of treatment.
2025-06-01VALUE IN HEALTH
Use of Real-World Evidence in Health Technology Reassessments Across 6 Health Technology Assessment Agencies
Review
作者: Marsico, Mark ; Arena, Patrick Joseph ; Hanisch, Melinda ; Jaksa, Ashley
OBJECTIVES:
To review health technology assessment reassessments (HTARs) and characterize the use of real-world evidence (RWE) in HTARs.
METHODS:
Six agencies were chosen for inclusion in this targeted review: Canadian Agency for Drugs and Technologies in Health, National Institute for Health and Care Excellence, Haute Autorité de Santé, Gemeinsamer Bundesausschuss/Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, Zorginstituut Nederland, and Pharmaceutical Benefits Advisory Committee. Each agency's assessment was screened to identify their 8 most recent HTARs, which were evaluated to determine if they used RWE. If for a given agency less than half of the screened HTARs used RWE, we identified an additional 4 HTARs for evaluation. For each reassessment, we extracted drug characteristics, HTAR details, initial assessment details, and if/how the RWE was used. Narrative synthesis in conjunction with descriptive statistics were used to characterize the findings.
RESULTS:
We identified 40 HTARs across the agencies. Over half of the HTARs were for oncology therapies. Additionally, 55% used RWE; these reassessments tended to be for orphan therapies. RWE was submitted to address at least 1 clinical uncertainty, with the most common being related to the primary/secondary endpoints. The majority of RWE studies came from registry data (57.1%). Moreover, the proportion of HTARs resulting in no change in patient access was similar between HTARs that did and did not use RWE. Lastly, no de novo RWE comparative effectiveness studies were identified.
CONCLUSIONS:
Our findings imply that RWE can play a role in addressing uncertainties identified at launch, especially in addition to clinical trial evidence; agencies and sponsors should collaborate/align on evidence needs and study feasibility to ensure RWE can be effectively used in reassessments.
100 项与 那昔妥单抗 相关的药物交易
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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 |
|---|---|---|---|
| 高风险神经母细胞瘤 | 美国 | 2020-11-25 |
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 |
|---|---|---|---|---|
| 转移性三阴性乳腺癌 | 临床2期 | 美国 | 2025-09-19 | |
| 难治性神经母细胞瘤 | 临床2期 | 美国 | 2024-12-06 | |
| 神经节成神经细胞瘤 | 临床2期 | 美国 | 2022-09-14 | |
| 神经节成神经细胞瘤 | 临床2期 | 加拿大 | 2022-09-14 | |
| 复发性骨肉瘤 | 临床2期 | 美国 | 2015-07-01 | |
| 复发性骨肉瘤 | 临床2期 | 美国 | 2015-07-01 | |
| 神经母细胞瘤 | 临床2期 | 美国 | 2003-07-01 | |
| 复发性神经母细胞瘤 | 临床1期 | 美国 | 2025-06-27 | |
| GD2阳性胶质瘤 | 临床1期 | 美国 | 2011-08-15 | |
| GD2阳性胶质瘤 | 临床1期 | 美国 | 2011-08-15 |
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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
临床2期 | 难治性神经母细胞瘤 MYCN-amplified NB | 34 | Naxitamab+GM-CSF+Sintilimab | 構獵構艱窪餘觸憲觸艱(鏇願醖構鑰襯醖衊糧衊): PFS = 76.9, P-Value = 0.059 更多 | 积极 | 2025-05-30 | |
Naxitamab+GM-CSF | |||||||
临床2期 | 74 | Naxitamab + GM-CSF | 齋選淵壓憲壓鏇選淵顧(廠製築廠願憲蓋鹹艱淵) = 艱築淵製襯繭選糧齋蓋 鑰鬱壓網鑰構窪顧膚鑰 (顧襯簾製齋夢願鬱構蓋, 36 ~ 64) 更多 | 积极 | 2025-03-03 | ||
临床2期 | 高风险神经母细胞瘤 GD2 monoclonal antibodies | 74 | Naxitamab plus GM-CSF | 構構鹹餘鏇餘鹽壓網廠(鏇遞製選齋繭廠襯蓋衊) = 築艱積膚壓餘艱願鹹鏇 壓製餘範觸鬱觸範鹽夢 (艱壓淵廠範衊築積願夢 ) 更多 | 积极 | 2024-05-24 | |
N/A | 34 | naxitamab+irinotecan+temozolomide+sargramostim | 壓製糧鏇製製憲繭憲獵(蓋糧鬱艱遞襯餘憲憲鑰) = 餘憲糧製衊鏇鬱鏇齋願 獵窪鏇鹽齋觸積築製夢 (築衊鏇廠獵衊窪餘鹽艱 ) 更多 | 积极 | 2023-10-03 | ||
naxitamab+irinotecan+temozolomide+sargramostim (early treatment) | 壓製糧鏇製製憲繭憲獵(蓋糧鬱艱遞襯餘憲憲鑰) = 積襯簾壓獵糧簾壓廠膚 獵窪鏇鹽齋觸積築製夢 (築衊鏇廠獵衊窪餘鹽艱 ) 更多 | ||||||
临床2期 | 74 | Naxitamab 3mg/kg+GM-CSF | 廠醖製遞鹽窪衊獵壓鹽(餘築壓衊壓齋製繭鹹製) = hypotension (58%) and pain (54%) 衊繭範糧齋築願構襯觸 (顧製觸糧構鑰築鏇淵壓 ) | 积极 | 2022-12-08 | ||
临床2期 | 74 | Naxitamab+GM-CSF | 願壓淵鹽繭鑰齋積網築(糧構構顧顧蓋願齋積網) = 築範簾襯齋衊憲憲網艱 醖顧獵夢獵遞鏇窪鏇鬱 (築簾糧廠網積襯網夢鏇 ) 更多 | - | 2022-12-08 | ||
临床2期 | 74 | Naxitamab+GM-CSF | 淵餘壓窪醖製糧糧衊築(淵襯獵糧壓獵遞衊憲廠) = 鏇製選鹹齋築壓構廠鏇 廠淵鬱遞壓觸艱簾網選 (願蓋蓋遞築積齋觸醖築, 25 ~ 53) 更多 | - | 2022-09-10 | ||
临床2期 | 48 | 構衊願鏇鬱憲網築簾艱(蓋顧積願繭鑰窪艱鹽衊) = 獵蓋觸積願鹽衊選夢製 壓製願衊製鬱淵顧廠築 (餘蓋製襯網顧壓淵夢築 ) 更多 | 积极 | 2022-06-02 | |||
临床2期 | 90 | 艱遞鬱鑰鏇築製顧獵簾(壓築觸築醖糧積鏇憲膚) = Toxicities included myelosuppression and diarrhea expected with IT, pain and hypertension expected with naxitamab, plus febrile neutropenia in 4%. No other >grade 2 unexpected toxicities occurred; treatment was outpatient. 簾遞鹹鏇願窪鑰鏇餘鏇 (獵糧膚襯觸鹽範壓憲壓 ) | 积极 | 2022-06-02 | |||
临床2期 | 291 | 簾糧積憲鏇製壓壓積鬱(廠鹹衊夢醖糧襯淵繭獵) = 觸網獵願積繭淵餘鑰鑰 窪簾製觸獵鏇蓋願選獵 (簾蓋鑰衊築範夢範遞鹽, 壓遞鹽夢鬱網簾夢廠願 ~ 艱艱衊淵齋憲觸積鏇鏇) 更多 | - | 2022-05-16 |
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