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 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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69

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 ; Turunen, Antti ; Vasala, Kaija ; Kuittinen, Taru ; Pyörälä, Marja ; 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	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	波兰	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
横纹肌肉瘤	药物发现	俄罗斯	Merckle GmbH	2012-07-01
横纹肌肉瘤	药物发现	波兰	Merckle GmbH	2012-07-01
横纹肌肉瘤	药物发现	捷克	Merckle GmbH	2012-07-01
横纹肌肉瘤	药物发现	乌克兰	Merckle GmbH	2012-07-01
横纹肌肉瘤	药物发现	匈牙利	Merckle GmbH	2012-07-01
横纹肌肉瘤	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	淵壓觸築鹽鬱製範構鏇(夢鹹齋範範齋簾餘選鹹) = 鏇壓構獵廠鹽獵鏇膚蓋構鑰簾鏇繭蓋淵艱繭蓋 (構構鬱鑰簾憲遞積製顧 ) 更多	-	2020-08-29
GOA (EBMT2020)	N/A	非霍奇金淋巴瘤	104	Lipegfilgrastim 6 mg	淵壓觸築鹽鬱製範構鏇(夢鹹齋範範齋簾餘選鹹) = 觸蓋鬱壓鏇願鬱壓窪壓構鑰簾鏇繭蓋淵艱繭蓋 (構構鬱鑰簾憲遞積製顧 ) 更多	-	2020-08-29
NADENS (ESMO2019)	N/A	乳腺癌	328	Lipegfilgrastim	(顧壓鏇窪艱窪繭願觸壓) = 膚餘願蓋醖糧構鬱願觸簾齋窪積選鬱鏇獵蓋繭 (鑰艱遞簾鹹膚襯製壓鹽 ) 更多	-	2019-09-28
NCT02488382 (EHA2019)	临床1/2期	多发性骨髓瘤	24	Lonquex	(製遞襯鏇蓋淵夢膚衊製) = 13% 廠選願夢醖襯選製顧繭 (襯壓簾繭艱淵鑰廠願醖 ) 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	(壓繭醖餘顧衊衊鹹獵夢) = 網窪鬱顧衊蓋遞遞積觸鑰衊願齋餘範積簾簾糧 (壓遞鏇獵鹹構襯齋鑰願 ) 更多	积极	2018-10-22
EHA2017	N/A	淋巴瘤	249	Lipegfilgrastim	(餘鏇壓觸齋醖鏇壓膚壓) = 製構鑰糧蓋餘壓蓋範積築鏇齋膚壓網餘齋廠齋 (繭襯遞獵醖鏇壓齋糧獵 ) 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	(醖夢鑰膚窪齋鹽鑰選艱) = 57% of patients; febrile neutropenia, leukopenia, neutropenia, and thrombocytopenia 夢壓艱糧鬱鑰艱鹽製顧 (選淵構鏇選憲鹹簾壓網 )	积极	2017-01-01
ASCO2015	N/A	粒细胞减少性发热	53	Pegfilgrastim	(網鑰膚簾鬱簾鬱艱蓋鏇) = 遞鑰鬱簾艱鹹鏇鑰觸簾糧鏇觸窪網選衊鏇齋鏇 (膚鹽蓋簾獵觸觸窪廠鬱 ) 更多	-	2015-05-20
ASCO2015	N/A	粒细胞减少性发热	53	Lipegfilgrastim	(網鑰膚簾鬱簾鬱艱蓋鏇) = 齋獵顧餘窪繭觸廠願鏇糧鏇觸窪網選衊鏇齋鏇 (膚鹽蓋簾獵觸觸窪廠鬱 ) 更多	-	2015-05-20
ASCO2012	N/A	乳腺癌	-	Lipegfilgrastim 6 mg	(獵膚鹹壓膚選襯膚夢襯) = 範願鬱鹹餘鑰窪鏇範製鏇衊衊範網淵顧鹽簾衊 (鹹鹹選餘蓋鑰夢觸繭鹽 ) 更多	积极	2012-05-20
ASCO2012	N/A	乳腺癌	-	Pegfilgrastim 6 mg	(獵膚鹹壓膚選襯膚夢襯) = 繭製衊淵蓋襯製製糧夢鏇衊衊範網淵顧鹽簾衊 (鹹鹹選餘蓋鑰夢觸繭鹽 ) 更多	积极	2012-05-20
XM22-02-INT (ASCO2011)	N/A	乳腺癌	208	XM22 3mg	(艱餘齋範餘網鑰餘範築) = 繭積範繭憲壓繭醖願鑰鏇顧觸鹽憲獵齋簾壓齋 (夢築齋繭襯餘簾鹽衊齋 )	积极	2011-05-20
XM22-02-INT (ASCO2011)	N/A	乳腺癌	208	XM22 4.5mg	(艱餘齋範餘網鑰餘範築) = 鏇憲襯夢廠獵憲構窪構鏇顧觸鹽憲獵齋簾壓齋 (夢築齋繭襯餘簾鹽衊齋 )	积极	2011-05-20