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

Start Date12 Jan 2021

Sponsor / Collaborator

Biocad CJSC

NCT04905329 / Unknown statusNot ApplicableIIT

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

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

100 Translational Medicine associated with Empegfilgrastim

100 Patents (Medical) associated with Empegfilgrastim

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

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	Phase 1	RU	Biocad CJSC	01 Sep 2013
Chemotherapy-Induced Febrile Neutropenia	Discovery	RU	Biocad CJSC	01 Sep 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DEFENDOR (ASCO2024)	Not Applicable	Solid tumor	3,218	Empegfilgrastim	tnwwbvybzy(swewfqbcxq) = ghrahiwqlx mqsoexdfsr (dfsnuwshfj )	Positive	24 May 2024
NCT01569087 (CTgov)	Phase 2	Chemotherapy-Induced Febrile Neutropenia \| Breast Cancer	60	empegfilrastim (Empegfilgrastim 3 mg)	ogargrbkvu(xmbyycudfq) = cimtgubknp visjbzkcbj (ehpuswzhyg, iifkzvewmz - wpwtffgzpe) View more	-	24 Oct 2016
				empegfilrastim (Empegfilgrastim 6 mg)	ogargrbkvu(xmbyycudfq) = mnanrokxud visjbzkcbj (ehpuswzhyg, ravnjeftth - vbtdtxkuvg) View more
NCT02104830 (CTgov)	Phase 3	Chemotherapy-Induced Febrile Neutropenia \| Breast Cancer	135	Placebo №2+Empegfilrastim 6 mg (Empegfilgrastim 6 mg)	mwetbyogos(fctmnogeqh) = mrbncbmozq vchzcjqfqk (twvblqqppa, xvwywcnxse - ccockplytx) View more	-	24 Oct 2016
				Placebo №2+Empegfilrastim 7.5 mg (Empegfilgrastim 7.5 mg)	mwetbyogos(fctmnogeqh) = kkbnctxfdm vchzcjqfqk (twvblqqppa, flbsjfztiy - pyrjtmbbmr) View more
NCT02104830 (ASCO2015) Manual	Phase 3	Neutropenia	135	empegfilgrastim 6 mg	(itjhgdpmmd) = zmpzvyehou xwodvehsed (dpfodzrdrv ) View more	Superior	29 May 2015
				empegfilgrastim 7.5 mg	(itjhgdpmmd) = atnlzlmmzo xwodvehsed (dpfodzrdrv ) View more
ASCO2012	Phase 1	-	24	BCD-017 1 mg	bqkttrkdva(xieasbquvk) = onfcjnysik wghmztrzpy (ooklmolmxp, 10.62 - 21.02) View more	-	20 May 2012
				BCD-017 3 mg	bqkttrkdva(xieasbquvk) = abfqwvbxim wghmztrzpy (ooklmolmxp, 15.43 - 28.07) View more

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