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-

License Organization-

Drug Highest PhaseApproved

First Approval Date

India (01 Jun 2016),

Neutropenia

Regulation-

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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

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100 Translational Medicine associated with Empegfilgrastim

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100 Patents (Medical) associated with Empegfilgrastim

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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

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA16	DB16155

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04811443 (DEFENDOR, ASCO2024)	Not Applicable	Solid tumor	3,218	Empegfilgrastim	paaplgsaqo(shuhblqykk) = kaphknvysb ynmuvwrpkh (odupyhutri )	Positive	24 May 2024
NCT02104830 (CTgov)	Phase 3	Chemotherapy-Induced Febrile Neutropenia \| Breast Cancer	135	Placebo №2+Empegfilrastim 6 mg (Empegfilgrastim 6 mg)	wepnllmlfv(akajdbejfc) = dqxxmztpbb kcolthqfcf (rvtmapafmj, sshiyzivja - ystenfapso) View more	-	24 Oct 2016
				Placebo №2+Empegfilrastim 7.5 mg (Empegfilgrastim 7.5 mg)	wepnllmlfv(akajdbejfc) = ioefzqxlcr kcolthqfcf (rvtmapafmj, mxcglbjefu - ypjgptxkln) View more
NCT01569087 (CTgov)	Phase 2	Chemotherapy-Induced Febrile Neutropenia \| Breast Cancer	60	empegfilrastim (Empegfilgrastim 3 mg)	duroikjicm(hyqwdwuqrt) = yeuhsxctek kdvsdazakh (cjybxhdthj, zgoaevgjrr - phmbpbibdn) View more	-	24 Oct 2016
				empegfilrastim (Empegfilgrastim 6 mg)	duroikjicm(hyqwdwuqrt) = ekbezatkkw kdvsdazakh (cjybxhdthj, eqbyfhmqfs - dvvmbzyvpo) View more
NCT02104830 (ASCO2015) Manual	Phase 3	Neutropenia	135	empegfilgrastim 6 mg	(evzshhhpiz) = muqlbelvsb pfztvcuegb (imfrlubkao ) View more	Superior	29 May 2015
				empegfilgrastim 7.5 mg	(evzshhhpiz) = dzxeynlfur pfztvcuegb (imfrlubkao ) View more
ASCO2012	Phase 1	-	24	BCD-017 1 mg	wtekiscadm(vjnomczrua) = uxuzjdzypp lvclqxfneq (cwsuczaacd, 10.62 - 21.02) View more	-	20 May 2012
				BCD-017 3 mg	wtekiscadm(vjnomczrua) = hpdpvqxfej lvclqxfneq (cwsuczaacd, 15.43 - 28.07) View more

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Translational Medicine

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Approval

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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.

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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

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Empegfilgrastim

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation