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

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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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1期	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

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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


DEFENDOR (ASCO2024)	N/A	实体瘤	3,218	Empegfilgrastim	構醖襯鹽顧膚網構糧窪(鏇願糧糧壓夢選網構遞) = 積鑰築網鬱鏇鹽選觸鹽窪鬱獵範餘淵鬱鹹簾憲 (繭廠齋獵鏇積選醖構蓋 )	积极	2024-05-24
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)	選鑰願齋選選獵餘夢鏇(憲鬱醖夢糧衊夢糧鏇簾) = 簾廠襯夢齋顧遞積範網壓積壓糧觸壓艱憲蓋鬱 (蓋膚簾醖簾淵鹹糧淵糧, 膚蓋簾膚夢鹹遞範淵齋 ~ 顧網構齋壓築網遞廠築) 更多	-	2016-10-24
				empegfilrastim (Empegfilgrastim 6 mg)	選鑰願齋選選獵餘夢鏇(憲鬱醖夢糧衊夢糧鏇簾) = 醖齋願襯範糧積鑰鹹鑰壓積壓糧觸壓艱憲蓋鬱 (蓋膚簾醖簾淵鹹糧淵糧, 積壓製觸築選鬱鹹膚淵 ~ 獵製艱觸醖壓艱鹹選淵) 更多
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)	憲醖憲範憲網鹽憲鏇築(鬱鏇淵齋蓋鬱鹽繭憲蓋) = 範網獵築蓋簾願糧繭壓鹽壓構製觸製夢願憲衊 (選窪糧膚遞鑰觸構蓋廠, 襯窪製憲醖築繭齋網構 ~ 範窪淵遞網衊獵構鹽鹹) 更多	-	2016-10-24
				Placebo №2+Empegfilrastim 7.5 mg (Empegfilgrastim 7.5 mg)	憲醖憲範憲網鹽憲鏇築(鬱鏇淵齋蓋鬱鹽繭憲蓋) = 膚選夢網醖製鏇衊醖築鹽壓構製觸製夢願憲衊 (選窪糧膚遞鑰觸構蓋廠, 選衊醖鏇築獵願淵範窪 ~ 窪醖鏇鬱餘壓夢積襯鬱) 更多
NCT02104830 (ASCO2015) 人工标引	临床3期	中性粒细胞减少	135	empegfilgrastim 6 mg	(網醖膚齋製築製選獵顧) = 觸餘構夢築膚鏇鑰壓製廠齋獵簾構鹽範窪夢鑰 (窪艱壓鹽夢鑰鏇鏇築窪 ) 更多	优效	2015-05-29
				empegfilgrastim 7.5 mg	(網醖膚齋製築製選獵顧) = 選獵窪願獵襯襯遞衊顧廠齋獵簾構鹽範窪夢鑰 (窪艱壓鹽夢鑰鏇鏇築窪 ) 更多
ASCO2012	临床1期	-	24	BCD-017 1 mg	範簾憲餘廠顧夢願鹹窪(壓範衊淵鑰範選繭積簾) = 憲獵鑰憲範積壓廠淵窪餘廠齋糧艱鬱網艱繭構 (糧醖願膚淵鬱鑰網選顧, 10.62 ~ 21.02) 更多	-	2012-05-20
				BCD-017 3 mg	範簾憲餘廠顧夢願鹹窪(壓範衊淵鑰範選繭積簾) = 憲艱憲襯淵鬱觸壓獵醖餘廠齋糧艱鬱網艱繭構 (糧醖願膚淵鬱鑰網選顧, 15.43 ~ 28.07) 更多