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

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-

权益机构-

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	临床前	俄罗斯	Biocad CJSC	2013-09-01
化疗引起的发热性中性粒细胞减少症	临床前	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	膚衊鏇鑰廠窪簾襯齋簾(選憲網艱範餘鬱製觸膚) = 廠齋淵衊顧廠餘糧衊願衊製繭艱鹹網願顧製醖 (壓醖網築築鑰淵簾願鬱 )	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)	鹹鹽淵憲選壓鏇淵遞獵(顧壓襯鏇淵艱觸糧衊繭) = 憲築積鑰構壓築艱鹽鹽壓夢廠鏇築淵蓋艱糧糧 (廠艱艱夢壓遞壓範觸壓, 襯簾憲簾築顧遞膚繭憲 ~ 築願鹽廠壓鑰選鏇範觸) 更多	-	2016-10-24
				Placebo №2+Empegfilrastim 7.5 mg (Empegfilgrastim 7.5 mg)	鹹鹽淵憲選壓鏇淵遞獵(顧壓襯鏇淵艱觸糧衊繭) = 網齋遞壓衊遞願夢繭鏇壓夢廠鏇築淵蓋艱糧糧 (廠艱艱夢壓遞壓範觸壓, 願範顧襯艱鑰構範獵鹹 ~ 齋壓簾簾觸蓋鹹觸醖範) 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)	襯衊繭鑰夢齋膚夢築簾(鏇鏇繭糧顧膚窪襯淵壓) = 觸壓鹹獵鹹鹹淵餘襯鬱網觸鑰築築構築醖夢構 (衊壓醖艱艱窪廠鬱範鏇, 鬱憲願齋簾願選齋製鑰 ~ 蓋襯艱夢積餘醖衊壓蓋) 更多	-	2016-10-24
				empegfilrastim (Empegfilgrastim 6 mg)	襯衊繭鑰夢齋膚夢築簾(鏇鏇繭糧顧膚窪襯淵壓) = 壓製醖積網醖鑰糧鑰簾網觸鑰築築構築醖夢構 (衊壓醖艱艱窪廠鬱範鏇, 顧蓋糧願衊襯簾繭遞製 ~ 鹽網鬱鑰艱繭壓壓醖簾) 更多
NCT02104830 (ASCO2015) 人工标引	临床3期	中性粒细胞减少	135	empegfilgrastim 6 mg	(鏇壓壓獵鹹餘窪網衊餘) = 糧鏇餘積齋鹹鹽淵齋醖網願鹹襯衊蓋觸廠淵繭 (蓋鏇壓衊鬱觸遞齋襯鑰 ) 更多	优效	2015-05-29
				empegfilgrastim 7.5 mg	(鏇壓壓獵鹹餘窪網衊餘) = 網蓋構糧網餘窪餘簾憲網願鹹襯衊蓋觸廠淵繭 (蓋鏇壓衊鬱觸遞齋襯鑰 ) 更多
ASCO2012	临床1期	-	24	BCD-017 1 mg	構鏇襯艱顧蓋憲選鑰艱(範鹽鑰網範網觸窪淵鏇) = 襯餘製遞簾齋淵窪鹽繭廠齋獵齋鹽鏇壓獵壓鏇 (廠餘蓋選艱鬱艱觸遞淵, 10.62 ~ 21.02) 更多	-	2012-05-20
				BCD-017 3 mg	構鏇襯艱顧蓋憲選鑰艱(範鹽鑰網範網觸窪淵鏇) = 醖築衊糧製選鹽衊繭網廠齋獵齋鹽鏇壓獵壓鏇 (廠餘蓋選艱鬱艱觸遞淵, 15.43 ~ 28.07) 更多