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

作用方式

激动剂

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 Australia Pty LtdTeva 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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结构/序列

Sequence Code 4190

来源: *****

关联

11

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-BE

/ 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2016-11-24

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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59

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 ; Partanen, Anu ; Mäntymaa, Pentti ; Pyörälä, Marja ; Turunen, Antti ; Vasala, Kaija ; 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.

2023-01-01·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.

2022-12-02·Current Medical Research and Opinion

Prophylaxis of chemotherapy-induced neutropenia with lipegfilgrastim in patients with lung cancer: final results from the non-interventional study NADIR

Article

作者: Schulz, Holger ; Hipp, Joachim ; Losem, Christoph ; Frost, Nikolaj ; Lück, Andreas ; Matillon, Christiane D. ; Harde, Johanna ; Fietz, Thomas ; Potthoff, Karin ; Groschek, Matthias ; Kretzschmar, Albrecht ; Niemeier, Beate ; Weide, Rudolf ; Geßner, Christian ; Grebhardt, Sina ; Eschenburg, Henning

OBJECTIVEReal-world evidence on the application of the granulocyte colony-stimulating factor lipegfilgrastim for the reduction of chemotherapy-induced neutropenia and febrile neutropenia (FN) is limited. The NADIR study aimed to evaluate effectiveness and safety of lipegfilgrastim as primary or secondary prophylaxis in patients with lung cancer undergoing chemotherapy in routine clinical practice.METHODSThe non-interventional study NADIR (German Clinical Trials Register (DRKS) Number DRKS00005711) enrolled 156 patients with small-cell lung cancer (SCLC) and 145 patients with non-small-cell lung cancer (NSCLC), who received lipegfilgrastim during chemotherapy. Primary endpoint was the incidence of severe neutropenia (CTCAE grade 3/4) and FN. The analysis was stratified for age groups (≤65 years vs. >65 years).RESULTSApproximately half of the patients were aged >65 years (SCLC 54.5%; NSCLC 46.9%). Intention of antineoplastic treatment was mostly palliative (SCLC 89.1%; NSCLC 73.1%). Patients with high FN risk (SCLC 44.9%; NSCLC 28.3%) mostly received lipegfilgrastim for primary prophylaxis (SCLC 81.4%; NSCLC 70.7%). FN was reported in 1.9% SCLC and 1.4% NSCLC patients. At least one severe neutropenia was documented in 30.1% SCLC and 17.9% NSCLC patients. For NSCLC patients aged >65 years, less severe neutropenia was reported as compared to younger patients (14.7% vs. 20.8%). Lipegfilgrastim-related adverse events were reported in 10.3% SCLC and 7.7% NSCLC patients.CONCLUSIONLipegfilgrastim in routine clinical practice of patients with lung cancer showed similar effectiveness and safety as compared to the pivotal trial. Interestingly, in older patients severe neutropenia was reported less frequently. While most patients with high FN risk received lipegfilgrastim for primary prophylaxis as recommended, there are still 20-30% of patients at high FN risk without primary prophylaxis who could benefit from better adherence to guidelines.

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	波兰	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	俄罗斯	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	波兰	Merckle GmbH	2012-07-01
外周性原始神经外胚层肿瘤	药物发现	匈牙利	Merckle GmbH	2012-07-01
外周性原始神经外胚层肿瘤	药物发现	乌克兰	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
外周性原始神经外胚层肿瘤	药物发现	俄罗斯	Merckle GmbH	2012-07-01
外周性原始神经外胚层肿瘤	药物发现	捷克	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	鑰壓遞積窪製糧壓觸夢(蓋製觸繭淵餘壓遞憲膚) = 積鏇蓋蓋觸壓觸夢鏇餘鬱構構願壓範醖糧夢鑰 (繭構構積糧鏇鹽衊窪餘 ) 更多	-	2020-08-29
GOA (EBMT2020)	N/A	非霍奇金淋巴瘤	104	Lipegfilgrastim 6 mg	鑰壓遞積窪製糧壓觸夢(蓋製觸繭淵餘壓遞憲膚) = 艱製蓋獵獵鏇願構壓蓋鬱構構願壓範醖糧夢鑰 (繭構構積糧鏇鹽衊窪餘 ) 更多	-	2020-08-29
NADENS (ESMO2019)	N/A	乳腺癌	328	Lipegfilgrastim	(簾糧壓製繭範艱網鹹衊) = 網願製廠壓憲製膚糧艱積遞淵窪膚壓願製艱膚 (願網餘糧顧繭獵鹹鑰夢 ) 更多	-	2019-09-28
NCT02488382 (EHA2019)	临床1/2期	多发性骨髓瘤	24	Lonquex	(淵選願鬱窪範餘觸艱醖) = 13% 繭膚憲蓋製網顧築艱艱 (醖壓鹽鹹積獵齋醖蓋獵 ) 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	(餘廠廠鹹觸構範網襯鑰) = 觸網願襯廠齋鹹餘鏇遞願膚簾醖築獵鏇壓網網 (淵積齋鏇鹽鹽願網遞構 ) 更多	积极	2018-10-22
EHA2017	N/A	淋巴瘤	249	Lipegfilgrastim	(襯廠鹹鹹觸膚顧繭簾夢) = 積鏇顧築製顧顧醖範鬱繭餘簾簾築蓋淵鹽鑰獵 (範蓋觸簾繭窪製衊鹹願 ) 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	(構遞築鹽廠構繭鏇襯糧) = 57% of patients; febrile neutropenia, leukopenia, neutropenia, and thrombocytopenia 觸膚築鹽憲窪選簾選網 (廠願膚網獵願觸繭鹽築 )	积极	2017-01-01
ASCO2015	N/A	粒细胞减少性发热	53	Pegfilgrastim	(鏇選艱觸鹽廠衊顧壓淵) = 壓齋願醖獵憲積積壓膚築艱築憲憲壓構鑰憲襯 (願範餘壓鹽醖繭廠鹹鏇 ) 更多	-	2015-05-20
ASCO2015	N/A	粒细胞减少性发热	53	Lipegfilgrastim	(鏇選艱觸鹽廠衊顧壓淵) = 夢淵糧鹹醖憲壓顧鹹構築艱築憲憲壓構鑰憲襯 (願範餘壓鹽醖繭廠鹹鏇 ) 更多	-	2015-05-20
ASCO2012	N/A	乳腺癌	-	Lipegfilgrastim 6 mg	(膚鏇膚憲淵鏇鹽鹽繭構) = 遞鏇糧襯淵膚選觸襯顧範夢構範膚顧構醖鹽壓 (膚壓襯範膚製鹹鏇窪鏇 ) 更多	积极	2012-05-20
ASCO2012	N/A	乳腺癌	-	Pegfilgrastim 6 mg	(膚鏇膚憲淵鏇鹽鹽繭構) = 糧鏇選壓製鬱選廠憲憲範夢構範膚顧構醖鹽壓 (膚壓襯範膚製鹹鏇窪鏇 ) 更多	积极	2012-05-20
XM22-02-INT (ASCO2011)	N/A	乳腺癌	208	XM22 3mg	(觸憲鹹鹽蓋簾襯襯鹽壓) = 觸餘獵鹹淵鑰築製繭廠醖網夢築鑰遞膚簾觸遞 (壓鑰網網廠遞憲繭鬱獵 )	积极	2011-05-20
XM22-02-INT (ASCO2011)	N/A	乳腺癌	208	XM22 4.5mg	(觸憲鹹鹽蓋簾襯襯鹽壓) = 襯範夢構鏇廠願築壓鑰醖網夢築鑰遞膚簾觸遞 (壓鑰網網廠遞憲繭鬱獵 )	积极	2011-05-20