利培非格司亭(Lipegfilgrastim) - 药物靶点：CSF-3R_在研适应症：粒细胞减少性发热，中性粒细胞减少_专利_临床

概要

基本信息

药物类型

集落刺激因子

别名

GlycoPEG-GCSF、GlycoPEGylated G-CSF、GlycoPEGylated granulocyte colony-stimulating factor

+ [7]

靶点

CSF-3R

作用机制

CSF-3R激动剂(巨噬细胞集落刺激因子3受体激动剂)

治疗领域

血液及淋巴系统疾病

在研适应症

粒细胞减少性发热中性粒细胞减少

非在研适应症

外周性原始神经外胚层肿瘤横纹肌肉瘤

原研机构

Teva Pharmaceutical Industries Ltd.

在研机构

Teva Pharmaceuticals Europe BVTeva-Handok Pharma Co., Ltd.

非在研机构

Merckle GmbH

最高研发阶段批准上市

首次获批日期

欧盟 (2013-07-25),

粒细胞减少性发热中性粒细胞减少

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 4190

来源: *****

关联

12

项与利培非格司亭相关的临床试验

ACTRN12618000055202 / Not yet recruiting临床4期IIT

LIPEG: A Phase IV, postmarketingstudy of the safety and efficacy of Lipegfigrastim (Lonquex ®) as febrileneutropenia (FN) prophylaxis in patients undergoing chemoimmunotherapy (CIT) for NonHodgkinLymphoma(NHL).

开始日期2018-02-05

申办/合作机构

Monash Health

NCT02488382 / Unknown status临床1/2期IIT

Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma

The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells for autologous stem cell transplantation in patients with lymphoma and multiple myeloma.

开始日期2017-07-01

申办/合作机构

Sheba Medical Center

EUCTR2015-000087-34-CZ / Not yet recruiting临床2期

An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 µg/kg Body Weight in Comparison to Filgrastim 5 µg/kg Body Weight in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy

开始日期2015-07-02

申办/合作机构

Merckle GmbH

100 项与利培非格司亭相关的临床结果

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100 项与利培非格司亭相关的转化医学

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100 项与利培非格司亭相关的专利（医药）

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65

项与利培非格司亭相关的文献（医药）

2023-11-01·Clinical Lymphoma Myeloma and Leukemia

Loss of CD34+ Cells and Effect of the Number of Viable Cryopreserved CD34+ Cells in the Infused Blood Grafts on Hematologic Recovery, Progression-Free Survival and Overall Survival in NHL Patients After Autologous Stem Cell Transplantation

Article

作者: Penttilä, Karri ; Jantunen, Esa ; Valtola, Jaakko ; Kuittinen, Outi ; Kuitunen, Hanne ; Mäntymaa, Pentti ; Partanen, Anu ; Pyörälä, Marja ; Vasala, Kaija ; Turunen, Antti ; Kuittinen, Taru ; Varmavuo, Ville ; Pelkonen, Jukka

PATIENTSThis post-hoc study aimed to find out factors affecting graft viable CD34⁺ cell loss during processing and cryopreservation in 129 non-Hodgkin lymphoma (NHL) patients receiving autologous stem cell transplantation (auto-SCT) and the impact of a low (< 2.0 × 10⁶/kg, group A) and a decent number (≥ 2 × 10⁶/kg, group B) of viable CD34⁺ cells infused on the hematologic recovery, progression-free survival (PFS) and overall survival (OS) after auto-SCT.RESULTSThe median loss of viable CD34⁺ cells during cryopreservation was higher in group A (47% vs. 19%, p < .001). A higher yield of CD34⁺ cells at the first apheresis in group B (p = .002) was linked with greater loss of viable graft CD34⁺ cells after cryopreservation. Filgrastim (FIL) use for mobilization seemed to associate with higher viable CD34⁺ cell loss compared to pegfilgrastim (PEG) or lipegfilgrastim (LIPEG) in both groups (in group A FIL 66 vs. PEG 35%, p = .006; in group B FIL 37 vs. PEG 15 vs. LIPEG 13%, p < .001). Hematologic recovery after auto-SCT was faster in group B. Neither viable CD34⁺ cell loss during storage nor viable CD34⁺ cell number < 2.0 × 10⁶/kg infused affected on PFS or OS.CONCLUSIONSG-CSF type used in mobilization and mobilization capacity were found to correlate with viable CD34⁺ cell loss during processing and storage. Most importantly, low infused viable CD34⁺ cell count did not seem to impact on PFS or OS.

2023-07-19·Cancers

Assessing the Optimal Regimen: A Systematic Review and Network Meta-Analysis of the Efficacy and Safety of Long-Acting Granulocyte Colony-Stimulating Factors in Patients with Breast Cancer.

Review

作者: Huang, Yining ; Zhao, Lei ; Zhang, Yuzhuo ; Tu, Hengjia ; Liang, Wenhua ; Zhang, Haotian ; Lin, Xinqing ; You, Zhixuan

Patients with breast cancer undergoing chemotherapy are susceptible to prolonged and severe neutropenia. Multiple biosimilars of long-acting granulocyte colony-stimulating factors (LA-G-CSFs) have been newly developed to prevent this disease. Nonetheless, which LA-G-CSF regimen has the optimal balance of efficacy and safety remains controversial. Moreover, there is a lack of evidence supporting clinical decisions on LA-G-CSF dose escalation in poor conditions. PubMed, Embase, Cochrane Library, Web of Science, and several Chinese databases were searched (December 2022) to collect randomized controlled trials (RCTs) about LA-G-CSFs preventing chemotherapy-induced neutropenia in breast cancer patients. No restrictions were imposed on language. A Bayesian network meta-analysis was performed. We assessed the incidence of severe neutropenia (SN) and febrile neutropenia (FN), the duration of SN (DSN), and the absolute neutrophil account recovery time (ANCrt) for efficacy, while the incidence of severe adverse events (SAE) was assessed for safety. The study was registered in PROSPERO (CRD42022361606). A total of 33 RCTs were included. Our network meta-analysis demonstrated that lipegfilgrastim 6 mg and eflapegrastim 13.2 mg outperformed other LA-G-CSFs with high efficacy rates and few safety concerns (SUCRA of lipegfilgrastim 6 mg: ANC rt 95.2%, FN 97.4%; eflapegrastim 13.2 mg: FN 87%, SN 89.3%). Additionally, 3.6 mg, 4.5 mg, 6 mg, and 13.2 mg dosages all performed significantly better than 1.8 mg in reducing the duration of SN (3.6 mg: DSN, SMD -0.68 [-1.13, -0.22; moderate]; 4.5 mg: -0.87 [-1.57, -0.17; low]; 6 mg: -0.89 [-1.49, -0.29; moderate]; 13.2 mg: -1.02 [1.63, -0.41; high]). Increasing the dosage from the guideline-recommended 6 mg to 13.2 mg can reduce both the duration and incidence of SN (SMD -0.13 [-0.24 to -0.03], RR 0.65 [0.43 to 0.96], respectively), with no significant difference in SAE. For patients with breast cancer, lipegfilgrastim 6 mg and eflapegrastim 13.2 mg might be the most effective regimen among LA-G-CSFs. Higher doses of LA-G-CSF may enhance efficacy without causing additional SAEs.

2023-01-01·Cancer Control

Outcome and Cost-Effectiveness Analysis of Long-acting G-CSF as Primary Prophylaxis of Neutropenia Induced by Chemotherapy in Breast Cancer Patients, From a Retrospective Study

Article

作者: Ma, Peizhi ; Wang, Yaqin ; Zhao, Chenglong ; Jiang, Dandan

Purpose This retrospective analysis aimed to evaluate the clinical outcomes and cost-effectiveness of long-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia caused by chemotherapy for breast cancer. Methods Patients with breast cancer who received long- or short-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia were enrolled in this study, and incidences of neutropenia were compared between two groups. A decision-analytic and a Markov model were used to compare the health benefits and costs of utilizing long- vs short-acting granulocyte-colony stimulating factor as the primary prophylaxis from the perspective of the Chinese health service system. Subsequently, one-way deterministic and probabilistic sensitivity analyses were conducted. The incremental cost-effectiveness ratios were calculated in baseline and sensitivity analyses. Results Patients receiving long-acting granulocyte-colony stimulating factor as the primary prophylaxis of chemotherapy-induced neutropenia experienced a significant lower incidence of this adverse event, compared with the short-acting one for 2 to 7 days. The outcomes of baseline analysis indicated that long-acting granulocyte-colony stimulating factor had a gain of 0.08 quality-adjusted life years and costed $149 more than the short-acting one, yielding an incremental cost-effectiveness ratio of $1792 per quality-adjusted life year. The sensitivity analysis proved the stability of our models and economic efficiency of long-acting granulocyte-colony stimulating factor. Conclusions Patients receiving long-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia experienced lower risk of this event compared with those underusing short-acting one. The long-acting granulocyte-colony stimulating factor may be a more cost-effective strategy for primary prophylaxis of neutropenia than short-acting one, considering the Chinese willingness-to-pay threshold of $12158.6 per quality-adjusted life year.

100 项与利培非格司亭相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10242	利培非格司亭	L03AA14	DB13200

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
粒细胞减少性发热	列支敦士登	Teva Pharmaceuticals Europe BV	2013-07-25
粒细胞减少性发热	冰岛	Teva Pharmaceuticals Europe BV	2013-07-25
粒细胞减少性发热	欧盟	Teva Pharmaceuticals Europe BV	2013-07-25
粒细胞减少性发热	挪威	Teva Pharmaceuticals Europe BV	2013-07-25
中性粒细胞减少	列支敦士登	Teva Pharmaceuticals Europe BV	2013-07-25
中性粒细胞减少	冰岛	Teva Pharmaceuticals Europe BV	2013-07-25
中性粒细胞减少	挪威	Teva Pharmaceuticals Europe BV	2013-07-25
中性粒细胞减少	欧盟	Teva Pharmaceuticals Europe BV	2013-07-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
外周性原始神经外胚层肿瘤	临床1期	俄罗斯	Merckle GmbH	2012-07-01
外周性原始神经外胚层肿瘤	临床1期	波兰	Merckle GmbH	2012-07-01
外周性原始神经外胚层肿瘤	临床1期	乌克兰	Merckle GmbH	2012-07-01
横纹肌肉瘤	临床1期	捷克	Merckle GmbH	2012-07-01
横纹肌肉瘤	临床1期	乌克兰	Merckle GmbH	2012-07-01
横纹肌肉瘤	临床1期	波兰	Merckle GmbH	2012-07-01
横纹肌肉瘤	临床1期	匈牙利	Merckle GmbH	2012-07-01
横纹肌肉瘤	临床1期	保加利亚	Merckle GmbH	2012-07-01
横纹肌肉瘤	临床1期	俄罗斯	Merckle GmbH	2012-07-01
外周性原始神经外胚层肿瘤	药物发现	保加利亚	Merckle GmbH	2012-07-01

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临床结果

适应症

分期

评价

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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


GOA (EBMT2020)	N/A	非霍奇金淋巴瘤	104	Pegfilgrastim 6 mg	範衊艱鹹淵蓋網構醖觸(觸鏇齋顧獵艱築範齋網) = 觸製獵網顧襯製鏇餘淵廠膚襯糧壓範醖簾窪醖 (積淵顧鹹範膚糧窪鬱鹽 ) 更多	-	2020-08-29
GOA (EBMT2020)	N/A	非霍奇金淋巴瘤	104	Lipegfilgrastim 6 mg	範衊艱鹹淵蓋網構醖觸(觸鏇齋顧獵艱築範齋網) = 願艱鹽壓憲繭範鹹窪衊廠膚襯糧壓範醖簾窪醖 (積淵顧鹹範膚糧窪鬱鹽 ) 更多	-	2020-08-29
NADENS (ESMO2019)	N/A	乳腺癌	328	Lipegfilgrastim	(壓網網餘願選壓糧構鑰) = 築壓顧顧齋夢觸衊襯顧蓋衊壓簾鹽餘夢選鑰構 (觸窪積衊觸範艱淵窪鹽 ) 更多	-	2019-09-28
NCT02488382 (EHA2019)	临床1/2期	多发性骨髓瘤	24	Lonquex	(鏇構壓構鏇餘夢觸蓋蓋) = 13% 繭構鑰鹽窪廠築憲壓窪 (窪築壓繭夢壓廠餘願壓 ) 更多	-	2019-06-15
ESMO2018	N/A	化疗引起的发热性中性粒细胞减少症	-	Lipegfilgrastim	(膚鬱鏇襯餘艱壓夢醖製) = 網餘壓願窪窪鑰齋顧構膚艱築餘願範積觸範醖 (繭鏇蓋範鏇鏇範廠鏇觸 ) 更多	积极	2018-10-22
EHA2017	N/A	淋巴瘤	249	Lipegfilgrastim	(衊廠襯糧顧選鑰衊積蓋) = 構壓範鑰憲獵顧選簾淵鹽製鹽積鹽窪壓夢膚膚 (鬱衊願餘願廠壓鹹蓋鏇 ) 更多	积极	2017-05-18
NCT01585649 (Pubmed \| Cancer Chemother Pharmacol) 人工标引	临床1期	外周性原始神经外胚层肿瘤 \| 横纹肌肉瘤	21	chemotherapy+lipegfilgrastim	(願憲淵遞餘壓築遞鏇夢) = 57% of patients; febrile neutropenia, leukopenia, neutropenia, and thrombocytopenia 構壓膚遞選夢顧遞窪簾 (構願網簾鏇顧範淵鬱選 )	积极	2017-01-01
ASCO2015	N/A	粒细胞减少性发热	53	Pegfilgrastim	(鹹鏇膚遞蓋窪鹹餘遞繭) = 壓繭願餘淵膚顧淵壓醖醖鏇獵觸廠構齋鏇獵鬱 (獵襯蓋夢製簾鑰簾鹹簾 ) 更多	-	2015-05-20
ASCO2015	N/A	粒细胞减少性发热	53	Lipegfilgrastim	(鹹鏇膚遞蓋窪鹹餘遞繭) = 壓網選構製網遞鏇憲選醖鏇獵觸廠構齋鏇獵鬱 (獵襯蓋夢製簾鑰簾鹹簾 ) 更多	-	2015-05-20
ASCO2012	N/A	乳腺癌	-	Lipegfilgrastim 6 mg	(鬱糧襯鹽蓋簾構鬱廠網) = 齋壓鑰蓋衊積窪鬱廠膚齋襯鹹積膚獵醖壓膚醖 (餘糧淵膚醖餘觸繭製製 ) 更多	积极	2012-05-20
ASCO2012	N/A	乳腺癌	-	Pegfilgrastim 6 mg	(鬱糧襯鹽蓋簾構鬱廠網) = 淵鬱壓選願齋齋獵鹹憲齋襯鹹積膚獵醖壓膚醖 (餘糧淵膚醖餘觸繭製製 ) 更多	积极	2012-05-20
XM22-02-INT (ASCO2011)	N/A	乳腺癌	208	XM22 3mg	(廠衊鏇襯憲艱壓糧窪鏇) = 鹽齋構鏇構構衊願糧鬱遞膚壓餘壓構艱鏇蓋願 (鏇艱遞蓋憲淵襯蓋糧鑰 )	积极	2011-05-20
XM22-02-INT (ASCO2011)	N/A	乳腺癌	208	XM22 4.5mg	(廠衊鏇襯憲艱壓糧窪鏇) = 願糧膚積衊糧淵齋選積遞膚壓餘壓構艱鏇蓋願 (鏇艱遞蓋憲淵襯蓋糧鑰 )	积极	2011-05-20