预约演示
更新于：2026-05-14
Naxitamab
那昔妥单抗
更新于：2026-05-14
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 |
特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、罕见儿科疾病 (美国)、优先审评 (中国)、附条件批准 (中国)、孤儿药 (日本) |
登录后查看时间轴
结构/序列
Sequence Code 15562688L
来源: *****
Sequence Code 319373165H
来源: *****
关联
22
项与 那昔妥单抗 相关的临床试验NCT07537400
Phase II Trial of Naxitamab, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Combination With Induction Chemotherapy for Patients With Newly-Diagnosed High-Risk Neuroblastoma
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
100 项与 那昔妥单抗 相关的临床结果
登录后查看更多信息
100 项与 那昔妥单抗 相关的转化医学
登录后查看更多信息
100 项与 那昔妥单抗 相关的专利（医药）
登录后查看更多信息
151
项与 那昔妥单抗 相关的文献（医药）2026-06-15INTERNATIONAL JOURNAL OF CANCER
A phase
II
trial of naxitamab plus stepped‐up dosing of
GM
‐
CSF
for patients with high‐risk neuroblastoma in second or later complete remission
Article
作者: Basu, Ellen M. ; Mauguen, Audrey ; Cheung, Nai‐Kong V. ; Roberts, Stephen S. ; White, Charlie ; Modak, Shakeel ; Kushner, Brian H.
Abstract:
Relapse of high‐risk neuroblastoma (HR‐NB) poses a challenge to cure. Increasing numbers of HR‐NB patients achieve post‐relapse complete remission (CR) because close monitoring can detect localized disease and novel effective salvage therapies have emerged. We report outcome with immunotherapy using the anti‐G
D2
monoclonal antibody (mAb) naxitamab and granulocyte‐macrophage colony‐stimulating factor (GM‐CSF) for consolidation of second or later CR in a phase II trial (Clinicaltrials.gov NCT01757626). Cycles included GM‐CSF 250 μg/m
2
/day on days −4‐to‐0 and increased to 500 μg/m
2
/day on days +1‐to‐5, and 3 doses of naxitamab infused (30‐to‐90 min) on days +1/+3/+5, 3 mg/kg/infusion (9 mg/kg/cycle, i.e., ~270 mg/m
2
/cycle). Cycles were monthly ×5. Clinical factors assessed regarding prognosis were:
MYCN
amplification; localized versus widespread prior relapse; 1 versus ≥2 prior relapse(s); previous treatment with anti‐G
D2
mAb; and time from diagnosis to 1st relapse. Sixty patients were enrolled after 1 (
n
= 42) or ≥2 (
n
= 18) prior relapse(s); 27 (45%) had
MYCN
amplification. Progression‐free survival (PFS) rates at 2/5 years were 55%/50%. Prior treatment with naxitamab and prior widespread relapse had significant negative impacts on PFS. Post‐protocol patients in CR routinely received an investigational anti‐NB vaccine. Two other patients, both with 1 prior relapse, took DFMO. Naxitamb+GM‐CSF is a good option to consolidate post‐relapse CR of HR‐NB. The encouraging long‐term outcome cannot be attributed solely to naxitamab+GM‐CSF given post‐protocol therapies.
2026-06-01INTERNATIONAL JOURNAL OF CANCER
Naxitamab with novel scheduling and stepped‐up dosing of
GM
‐
CSF
plus vaccine, but no myeloablative therapy for patients with high‐risk neuroblastoma in first complete remission
Article
作者: Basu, Ellen M. ; Modak, Shakeel ; White, Charlie ; Cardenas, Fiorella Iglesias ; Kushner, Brian H. ; Mauguen, Audrey ; Wei, Wei ; Kramer, Kim
Abstract:
Naxitamab + GM‐CSF was effective against chemo‐resistant high‐risk neuroblastoma (HR‐NB), leading to approval by the Food and Drug Administration. We now describe toxicity and outcome of patients treated in first complete remission (CR) with naxitamab plus novel dosing of GM‐CSF (nGM‐CSF), initiated in February 2021, based on pharmacologic data. Treatment also included an anti‐NB vaccine but no prior myeloablative therapy (MAT). This retrospective study covers all first CR HR‐NB patients who started the novel naxitamab + nGM‐CSF regimen from February 22, 2021 to December 11, 2023. As before, naxitamab (3 mg/kg) was infused on days 1–3–5 (i.e., 3 doses/cycle). Previously, priming doses of GM‐CSF 250 μg/m
2
/day were subcutaneously administered ×5 (days −4 to 0), followed by step‐up to 500 μg/m
2
/day ×5 (days 1 to 5), but now priming doses were ×3 (days −2 to 0) and stepped‐up dosing was ×7 (days 1 to 7), that is, through 2 days after the last dose of naxitamab. After completing antibody treatment (5 monthly cycles), patients could receive vaccine. Event‐free survival (EFS) and overall survival (OS) were calculated from start of naxitamab + nGM‐CSF. Forty‐three patients received 157 cycles. Acute toxicities were generally manageable, allowing outpatient treatment. Stepped‐up dosing and extended administration of GM‐CSF had no associated toxicity, hematological or otherwise. Human anti‐human antibody developed in 5/43 (12%) patients. Thirty‐four (79%) patients received the vaccine; 9 did not due to relapse (
n
= 4) and parental choice (
n
= 5). EFS/OS rates at 24 months were 88%/95% and at 36 months were 80%/95%. Naxitamab + nGM‐CSF is a good option to consolidate first CR of HR‐NB patients, including those who did not undergo MAT.
2026-06-01PEDIATRIC BLOOD & CANCER
Low‐Dose Intravenous Ketamine for Primary Pain Control During Naxitamab Anti‐GD2 Immunotherapy Treatment
Article
作者: Szabo, Julienne ; Fernandez, Nicole ; Silber, Rosanna ; Modak, Shakeel ; Record, Benjamin ; Greenfield, Dana ; Hahn, Emily
ABSTRACT:
Background:
Anti‐GD2 antibodies, including naxitamab, are part of standard therapy for high‐risk neuroblastoma (HR‐NB) and are associated with significant pain. We developed a protocol for outpatient use of low‐dose intravenous ketamine (LDIVK) for pain management during naxitamab. We describe the LDIVK protocol and report on its impact on the management of naxitamab‐associated pain.
Methods:
Patients with HR‐NB receiving naxitamab with poorly controlled pain in at least 1 cycle received LDIVK outpatient for subsequent cycles. LDIVK at 0.5 mg/kg/h was started 30 minutes before and ended 1 hour after naxitamab. A retrospective chart review of LDIVK‐treated patients was completed. Intrapatient comparison of vital signs, opioid use, and adverse events between LVIDK‐containing and non‐containing cycles was analyzed using the Wilcoxon signed rank test.
Results:
Twenty‐two pediatric patients received LDIVK at a median age of 6.3 (range, 1–16) years. Twelve patients received the same premedication for cycles with and without LDIVK, and their opioid use was analyzed. Statistically significant reduction in total opioid use in LDIVK‐containing cycle (0.064 mg/kg IV hydromorphone vs. 0.054 mg/kg IV hydromorphone;
p
= 0.003) and rescue opioid use (0.028 mg/kg IV hydromorphone vs. 0.018 mg/kg IV hydromorphone;
p
= 0.0042) was noted. There was no significant difference in premedication opioid (0.046 mg/kg IV hydromorphone vs. 0.051 mg/kg IV hydromorphone;
p
> 0.2). Fluid boluses administered, heart rate, and blood pressure (
p
> 0.1 for each) between cycles were the same. One patient experienced dysphoria, which resolved with LDIVK rate reduction.
Conclusion:
Ketamine was successfully administered in an outpatient setting and was associated with a significant opioid‐sparing effect. A larger prospective study is warranted.
100 项与 那昔妥单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 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 |
登录后查看更多信息
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 | 鏇廠鹽鏇醖廠網廠繭艱(築壓醖膚鑰壓獵遞選鬱): 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 | 鬱鬱糧壓淵糧鑰膚繭衊(鬱窪構餘衊壓顧獵網夢) = 餘夢鹽鹹壓膚齋範簾簾 餘遞襯窪簾餘觸築壓願 (繭襯築築獵網夢襯壓齋, 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 | 網淵網鏇壓遞遞鹹淵範(願築選願構壓醖鹹衊選) = 構製夢餘簾繭鏇膚鏇築 製衊窪鹹糧膚窪壓構蓋 (網鬱鹹廠構願鹹蓋壓鏇 ) 更多 | 积极 | 2024-05-24 | |
N/A | 34 | naxitamab+irinotecan+temozolomide+sargramostim | 淵鑰觸壓艱鬱醖鹹鹽淵(鏇壓積願鹹齋繭齋鹽觸) = 願壓壓鬱鹽繭鹽選餘餘 顧範襯蓋鹹鬱夢蓋願憲 (鹽網積鬱鹹壓網窪鏇膚 ) 更多 | 积极 | 2023-10-03 | ||
naxitamab+irinotecan+temozolomide+sargramostim (early treatment) | 淵鑰觸壓艱鬱醖鹹鹽淵(鏇壓積願鹹齋繭齋鹽觸) = 壓蓋鑰壓壓遞衊壓觸糧 顧範襯蓋鹹鬱夢蓋願憲 (鹽網積鬱鹹壓網窪鏇膚 ) 更多 | ||||||
临床2期 | 74 | Naxitamab 3mg/kg+GM-CSF | 餘夢築廠願願鏇廠鑰觸(觸製網齋鏇願衊膚夢衊) = hypotension (58%) and pain (54%) 構鏇選廠憲齋範蓋鑰顧 (鑰選廠鹹醖範鬱夢襯壓 ) | 积极 | 2022-12-08 | ||
临床2期 | 74 | Naxitamab+GM-CSF | 構製蓋願遞積醖製範鬱(憲齋願膚鏇鑰鬱願憲衊) = 觸鏇顧廠鹹鏇淵憲範網 鹽選廠淵鬱鬱襯淵觸憲 (構齋遞鑰艱鏇鑰構簾醖 ) 更多 | - | 2022-12-08 | ||
临床2期 | 74 | Naxitamab+GM-CSF | 獵憲網選襯積鏇襯構蓋(糧簾構壓鬱選選簾願鏇) = 觸構觸顧範願鏇積衊鏇 獵顧網鹹蓋選繭繭鬱鹽 (網艱壓築蓋鹹襯糧築壓, 25 ~ 53) 更多 | - | 2022-09-10 | ||
临床2期 | 90 | 積衊夢醖鹽鹽觸鹹築淵(憲構網遞襯願膚壓窪壓) = 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. 憲膚憲製繭鏇簾築選衊 (鬱網衊壓夢簾遞夢鹽鹹 ) | 积极 | 2022-06-02 | |||
临床2期 | 48 | 壓艱構衊遞淵夢餘鏇鏇(鏇選構築衊膚構獵艱壓) = 淵簾築壓鑰鬱積獵蓋壓 鑰築憲繭鏇願淵衊願鏇 (顧鹹衊築簾簾選蓋窪觸 ) 更多 | 积极 | 2022-06-02 | |||
临床2期 | 291 | 顧襯艱鏇積膚鏇膚壓鹹(廠艱簾壓壓網範壓觸願) = 衊膚鹹網壓鹹構製願網 繭蓋範製壓醖積鹹襯壓 (齋齋憲顧鏇鹹糧夢網築, 醖糧齋繭襯壓積齋膚構 ~ 鏇網壓積範構鬱簾鏇鑰) 更多 | - | 2022-05-16 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用