Delving into the Latest Updates on Empegfilgrastim with Synapse

Overview

Basic Info

Drug Type

Colony-stimulating factors

Synonyms

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

+ [1]

Target

CSF-3R

Action

agonists

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Neutropenia

Inactive Indication

Breast CancerChemotherapy-Induced Febrile Neutropenia

Originator Organization

Biocad Medical, Inc.

Active Organization

Biocad CJSCBiocad Medical, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

India (01 Jun 2016),

Neutropenia

Regulation-

Login to view timeline

Structure/Sequence

Sequence Code 4190

Source: *****

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

Start Date28 Apr 2020

Sponsor / Collaborator

Moscow Clinical Scientific Center

NCT02104830

/ CompletedPhase 3

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).

Start Date01 Sep 2013

Sponsor / Collaborator

Biocad CJSC

100 Clinical Results associated with Empegfilgrastim

Login to view more data

100 Translational Medicine associated with Empegfilgrastim

Login to view more data

100 Patents (Medical) associated with Empegfilgrastim

Login to view more data

1

Literatures (Medical) associated with Empegfilgrastim

Scientific Reports

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

Review

Author: 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 Deals associated with Empegfilgrastim

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA16	DB16155

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Neutropenia	-	Biocad Medical, Inc.	-

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Discovery	Russia	Biocad CJSC	01 Sep 2013
Chemotherapy-Induced Febrile Neutropenia	Discovery	Russia	Biocad CJSC	01 Sep 2013

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04811443 (DEFENDOR, ASCO2024)	Not Applicable	Solid tumor	3,218	Empegfilgrastim	cpphxjaxle(vcavnflzdz) = reymrksqsl xpovklngnp (nvxrlwexuu )	Positive	24 May 2024
NCT01569087 (CTgov)	Phase 2	Chemotherapy-Induced Febrile Neutropenia \| Breast Cancer	60	empegfilrastim (Empegfilgrastim 3 mg)	fnbzrtwovy(mlscxmcfpc) = ejinkitigf leocmxzytc (pjaqtvsrxt, ltaccvwqwd - hbbchlcjml) View more	-	24 Oct 2016
				empegfilrastim (Empegfilgrastim 6 mg)	fnbzrtwovy(mlscxmcfpc) = muiixdzeao leocmxzytc (pjaqtvsrxt, mjayhkwfnf - kjkfrtpksm) View more
NCT02104830 (CTgov)	Phase 3	Chemotherapy-Induced Febrile Neutropenia \| Breast Cancer	135	Placebo №2+Empegfilrastim 6 mg (Empegfilgrastim 6 mg)	ennsrjkwiz(hrvqwxysph) = xldujfjsdi ewlyfrngmh (tnbcpcpkfg, lfuecvopll - xlxeqkyapq) View more	-	24 Oct 2016
				Placebo №2+Empegfilrastim 7.5 mg (Empegfilgrastim 7.5 mg)	ennsrjkwiz(hrvqwxysph) = bowxblenau ewlyfrngmh (tnbcpcpkfg, rjnqurcekk - nwxhapgtki) View more
NCT02104830 (ASCO2015) Manual	Phase 3	Neutropenia	135	empegfilgrastim 6 mg	(yeyxudidgh) = wgwvpryxvi ezozapjaff (rsqvqgfpdp ) View more	Superior	29 May 2015
				empegfilgrastim 7.5 mg	(yeyxudidgh) = tjltetulov ezozapjaff (rsqvqgfpdp ) View more
ASCO2012	Phase 1	-	24	BCD-017 1 mg	jwahuajqfb(eljpzydqhi) = atqttivmdd rbmepcropa (poepfxgvsl, 10.62 - 21.02) View more	-	20 May 2012
				BCD-017 3 mg	jwahuajqfb(eljpzydqhi) = jsgbbmeupm rbmepcropa (poepfxgvsl, 15.43 - 28.07) View more

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.

Empegfilgrastim

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation