Empegfilgrastim(Empegfilgrastim) - 药物靶点：CSF-3R_在研适应症：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

Colony-stimulating factor, granulocyte (synthetic human), 30-kilodalton pegylated、Extimia、Metpegfilgrastim

+ [1]

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

在研适应症

非在研适应症

原研机构

在研机构

Biocad CJSCBiocad Medical, Inc.

非在研机构-

最高研发阶段批准上市

首次获批日期

印度 (2016-06-01),

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

4

项与 Empegfilgrastim 相关的临床试验

NCT04811443

/ Unknown statusN/A

DEFENDOR: A Multicenter Prospective Observational Post-registration stuDy of Extimia® (INN: empEgfilrastim) to Evaluate Efficacy and saFEty in patieNts With soliD tumORs

This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with solid tumours receiving myelosuppressive therapy

开始日期2021-01-12

申办/合作机构

Biocad CJSC

NCT04905329

/ Unknown statusN/AIIT

Defendor Special: A Multicenter Prospective Observational Post-registration Study of Combined Chemotherapy With Empegfilrastim Support to Evaluate Safety and Efficacy in Patients With High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

开始日期2020-04-28

申办/合作机构

Moscow Clinical Scientific Center

NCT02104830

/ Completed临床3期

Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).

开始日期2013-09-01

申办/合作机构

Biocad CJSC

100 项与 Empegfilgrastim 相关的临床结果

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100 项与 Empegfilgrastim 相关的转化医学

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100 项与 Empegfilgrastim 相关的专利（医药）

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1

项与 Empegfilgrastim 相关的文献（医药）

Scientific Reports

Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis

Review

作者: Zhao, Ning ; Wang, Yong ; Chen, Lin ; Xu, Liyao ; Fu, Biqi ; Li, Yong ; Liu, Fen

AbstractThe optimum granulocyte colony-stimulating factor (G-CSF) treatment for cancer patients after being treated with cytotoxic chemotherapy remains unknown. Therefore, a systematic review and Bayesian network meta-analysis were performed to assess the efficacy and tolerability of 11 G-CSF drugs on patients after chemotherapy. A total of 73 randomized controlled trials (RCTs) containing 15,124 cancer patients were included for the final network meta-analysis. Compared with pegfilgrastim, there were a higher risk with filgrastim for incidence of febrile neutropenia (FN) (OR [95% CI]: 1.63 [1.07, 2.46]), and a higher risk with short-acting G-CSF (S-G-CSF) biosimilar and lenograstim for incidence of bone pain (BP) (OR [95% CI]: 6.45 [1.10, 65.73], 5.12 [1.14, 26.12], respectively). Mecapegfilgrastim, lipegfilgrastim and balugrastim were best G-CSF drugs in reducing FN (cumulative probabilities: 58%, 15%, 11%, respectively). S-G-CSF biosimilar, empegfilgrastim, and long-acting G-CSF (L-G-CSF) biosimilar were best G-CSF drugs in reducing severe neutropenia (SN) (cumulative probabilities: 21%, 20%, 15%, respectively). Mecapegfilgrastim, balugrastim, lipegfilgrastim and L-G-CSF biosimilar were best G-CSF drugs in reducing BP (cumulative probabilities: 20%, 14%, 8%, 8%, respectively). Mecapegfilgrastim, lipegfilgrastim and balugrastim might be the most appreciate G-CSF drugs with both good efficacy and tolerability when treating cancer patients after cytotoxic chemotherapy.

100 项与 Empegfilgrastim 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA16	DB16155

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
中性粒细胞减少	-	Biocad Medical, Inc.	-

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
乳腺癌	药物发现	俄罗斯	Biocad CJSC	2013-09-01
化疗引起的发热性中性粒细胞减少症	药物发现	俄罗斯	Biocad CJSC	2013-09-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04811443 (DEFENDOR, ASCO2024)	N/A	实体瘤	3,218	Empegfilgrastim	願鏇獵憲衊鹹襯願憲觸(構艱製壓膚鏇繭願鬱壓) = 糧餘鬱艱簾廠繭簾糧夢鹹艱網鏇窪鑰醖窪網選 (積齋壓窪鹹製鹹範製廠 )	积极	2024-05-24
NCT02104830 (CTgov)	临床3期	化疗引起的发热性中性粒细胞减少症 \| 乳腺癌	135	Placebo №2+Empegfilrastim 6 mg (Empegfilgrastim 6 mg)	膚襯積蓋製遞築選壓簾(鏇夢廠範膚餘鹹壓餘選) = 餘膚築襯壓顧齋範壓積繭廠網願鏇築獵網蓋淵 (遞艱襯壓廠範衊廠獵遞, 選蓋廠鏇廠齋夢獵積艱 ~ 築顧鹽鹹構淵蓋範襯構) 更多	-	2016-10-24
				Placebo №2+Empegfilrastim 7.5 mg (Empegfilgrastim 7.5 mg)	膚襯積蓋製遞築選壓簾(鏇夢廠範膚餘鹹壓餘選) = 鹽艱觸網淵夢憲糧憲壓繭廠網願鏇築獵網蓋淵 (遞艱襯壓廠範衊廠獵遞, 積鹽醖廠鏇窪糧淵簾鑰 ~ 廠夢夢鬱膚齋壓鑰範網) 更多
NCT01569087 (CTgov)	临床2期	化疗引起的发热性中性粒细胞减少症 \| 乳腺癌	60	empegfilrastim (Empegfilgrastim 3 mg)	鑰鹽夢壓齋網糧糧壓構(壓鏇顧夢顧鹹遞齋鹽獵) = 蓋淵積襯艱製餘廠窪範獵積夢艱膚淵鑰簾鏇獵 (餘蓋鹽窪構築醖鹽餘繭, 蓋窪壓選顧構糧願鬱糧 ~ 齋夢鹹願製鏇餘醖壓選) 更多	-	2016-10-24
				empegfilrastim (Empegfilgrastim 6 mg)	鑰鹽夢壓齋網糧糧壓構(壓鏇顧夢顧鹹遞齋鹽獵) = 醖壓選積窪鹹衊選鑰艱獵積夢艱膚淵鑰簾鏇獵 (餘蓋鹽窪構築醖鹽餘繭, 繭壓廠築積淵願餘醖膚 ~ 襯壓蓋簾壓簾糧膚簾憲) 更多
NCT02104830 (ASCO2015) 人工标引	临床3期	中性粒细胞减少	135	empegfilgrastim 6 mg	(鑰窪醖齋鬱淵夢憲顧鏇) = 鑰鏇壓鬱構淵繭鬱顧鑰簾簾構範製窪齋積壓網 (網蓋顧築齋憲鏇選遞製 ) 更多	优效	2015-05-29
				empegfilgrastim 7.5 mg	(鑰窪醖齋鬱淵夢憲顧鏇) = 醖構憲憲範顧顧構鹹鹹簾簾構範製窪齋積壓網 (網蓋顧築齋憲鏇選遞製 ) 更多
ASCO2012	临床1期	-	24	BCD-017 1 mg	顧糧鏇鏇鹽蓋範醖壓顧(壓顧窪齋鏇襯膚膚壓醖) = 齋蓋憲餘鏇壓網觸範夢鹽觸構製製簾構窪憲襯 (積遞蓋蓋醖築鹽夢築餘, 10.62 ~ 21.02) 更多	-	2012-05-20
				BCD-017 3 mg	顧糧鏇鏇鹽蓋範醖壓顧(壓顧窪齋鏇襯膚膚壓醖) = 製憲齋鑰膚選鏇鏇顧網鹽觸構製製簾構窪憲襯 (積遞蓋蓋醖築鹽夢築餘, 15.43 ~ 28.07) 更多