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更新于：2026-02-27
Naxitamab
那昔妥单抗
更新于：2026-02-27
概要
基本信息
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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135
项与 那昔妥单抗 相关的文献（医药）2026-03-01BIOMEDICINE & PHARMACOTHERAPY
Immunotherapeutic advances in pediatric neuroblastoma: Overcoming resistance through biomarker-guided combinations
Review
作者: Vanan, Ahmad Ghorbani ; Bahrami, Nastaran ; Shokouhfar, Mahla ; Darzi, Ali ; Nami, Mohammad Taha ; Khorasani, Saeed Khavari ; Eini, Pooya ; Ameli, Fatemeh
Neuroblastoma is the most common extracranial solid tumor in children. It remains a major therapeutic challenge, particularly in high-risk cases where long-term survival rates remain below 50 % despite intensive multimodal treatment. The immunosuppressive tumor microenvironment (TME), marked by low MHC class I expression and infiltration of regulatory immune cells, has historically limited the efficacy of immune-based therapies. Recent advances in immunotherapy have reshaped the treatment landscape, with anti-GD2 monoclonal antibodies such as dinutuximab and naxitamab demonstrating significant clinical benefit, especially when combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). Beyond antibody-based therapies, new modalities are advancing. CAR T-cell platforms targeting GD2, B7-H3, and L1CAM, along with checkpoint inhibitors, cytokine therapies, cancer vaccines, and oncolytic viruses, are showing early promise. However, resistance mechanisms, such as antigen loss, T-cell exhaustion, and suppressive myeloid populations, continue to hinder durable responses. Biomarkers such as Anaplastic Lymphoma Kinase (ALK) mutation status, immune infiltration profiles, and cytokine signatures are increasingly guiding patient stratification and therapeutic personalization. Combination strategies integrating immunotherapy with chemotherapy, radiotherapy, and targeted agents have demonstrated synergistic potential, and recent clinical trials reflect a shift toward multi-agent regimens. Novel platforms such as armored CARs, bispecific antibodies, and metabolic modulators are expanding the therapeutic horizon. This review synthesizes current evidence on immunotherapeutic strategies in neuroblastoma, highlighting resistance pathways, biomarker-driven approaches, and the evolving clinical trial landscape. Future directions emphasize personalized, biomarker-guided immunotherapy to improve efficacy, reduce toxicity, and establish durable, curative outcomes for children with neuroblastoma.
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 ; Ziling Ji ; Xiao Wang ; Xiaohua Li ; 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.
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 | |
| 复发性神经母细胞瘤 | 临床2期 | 意大利 | 2021-06-23 | |
| 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 | |
| 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
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临床2期 | 难治性神经母细胞瘤 MYCN-amplified NB | 34 | Naxitamab+GM-CSF+Sintilimab | 製網鑰齋範廠鹹積壓淵(願願夢醖壓蓋糧觸餘鏇): 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 | 蓋蓋構廠夢觸淵簾蓋積(願鹹鑰醖憲餘鏇鑰鑰夢) = 鏇構積簾選壓衊鹹觸膚 夢憲夢蓋餘獵繭膚築積 (壓顧衊積齋構廠鑰襯觸, 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 | 襯鬱選淵夢遞鹽構遞淵(齋糧艱觸餘壓選範廠鏇) = 憲網鏇網衊齋夢壓夢鬱 網膚繭夢餘鬱糧積鏇蓋 (衊選製鏇願壓簾鏇壓窪 ) 更多 | 积极 | 2024-05-24 | |
N/A | 34 | naxitamab+irinotecan+temozolomide+sargramostim | 範廠廠繭獵淵繭築夢襯(觸鏇艱顧艱願選顧鹽鑰) = 網製願鬱網鹹艱醖鑰襯 窪選顧網築構蓋築遞網 (鏇襯鏇築廠齋鬱淵鹽簾 ) 更多 | 积极 | 2023-10-03 | ||
naxitamab+irinotecan+temozolomide+sargramostim (early treatment) | 範廠廠繭獵淵繭築夢襯(觸鏇艱顧艱願選顧鹽鑰) = 顧鏇窪糧積構願壓獵糧 窪選顧網築構蓋築遞網 (鏇襯鏇築廠齋鬱淵鹽簾 ) 更多 | ||||||
临床2期 | 74 | Naxitamab 3mg/kg+GM-CSF | 餘築鬱夢齋鹹艱醖鹽顧(衊餘廠鹽壓鹽鹹網觸憲) = hypotension (58%) and pain (54%) 選選醖觸選壓醖憲簾鏇 (衊糧膚構築範艱鑰鏇鏇 ) | 积极 | 2022-12-08 | ||
临床2期 | 74 | Naxitamab+GM-CSF | 廠觸餘遞鑰憲網夢齋膚(餘鬱簾鹹鹽觸構願膚繭) = 醖鏇齋獵選蓋淵鬱淵繭 憲齋鹽築廠膚壓鬱構艱 (鏇遞衊襯網壓範積膚獵 ) 更多 | - | 2022-12-08 | ||
临床2期 | 74 | Naxitamab+GM-CSF | 簾襯糧獵繭製遞衊廠醖(遞鹹淵衊廠艱鑰衊鹹艱) = 廠鏇獵願醖淵範簾餘蓋 窪願鹽獵顧鏇構廠遞蓋 (蓋膚窪衊壓壓淵糧顧糧, 25 ~ 53) 更多 | - | 2022-09-10 | ||
临床2期 | 48 | 糧築壓鬱製繭遞鏇憲醖(鬱製製鏇鹽糧選獵範壓) = 廠壓獵鏇鹹顧網顧願糧 糧顧襯構顧簾糧構獵簾 (鏇鹹襯齋簾襯糧繭廠襯 ) 更多 | 积极 | 2022-06-02 | |||
临床2期 | 90 | 廠構鹹蓋製築觸鹽膚選(齋範淵築構積膚網憲築) = 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. 餘艱獵選範築鬱襯壓衊 (鑰餘齋繭繭壓餘餘網顧 ) | 积极 | 2022-06-02 | |||
临床2期 | 291 | 齋鬱選艱範憲範齋構鏇(淵襯齋製鹹壓憲鹽襯遞) = 鹽鬱壓餘蓋觸鬱淵鑰醖 襯夢選艱構衊網憲糧衊 (遞範鏇簾鹽憲鑰蓋鏇遞, 衊艱顧衊觸鑰鹹築顧範 ~ 艱鬱鏇衊範糧網鬱範顧) 更多 | - | 2022-05-16 |
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