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Last update 16 May 2025
Lipegfilgrastim
Last update 16 May 2025
Overview
Basic Info
Drug Type Colony-stimulating factors |
Synonyms GlycoPEG-GCSF, GlycoPEGylated G-CSF, GlycoPEGylated granulocyte colony-stimulating factor + [7] |
Target |
Action agonists |
Mechanism CSF-3R agonists(Colony stimulating factor 3 receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date European Union (25 Jul 2013), |
Regulation- |
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Structure/Sequence
Sequence Code 4190
Source: *****
Related
11
Clinical Trials associated with LipegfilgrastimACTRN12618000055202
LIPEG: A Phase IV, postmarketingstudy of the safety and efficacy of Lipegfigrastim (Lonquex ®) as febrileneutropenia (FN) prophylaxis in patients undergoing chemoimmunotherapy (CIT) for NonHodgkinLymphoma(NHL).
NCT02488382
Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma
EUCTR2015-000087-34-BE
An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 µg/kg Body Weight in Comparison to Filgrastim 5 µg/kg Body Weight in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy
100 Clinical Results associated with Lipegfilgrastim
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100 Translational Medicine associated with Lipegfilgrastim
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100 Patents (Medical) associated with Lipegfilgrastim
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59
Literatures (Medical) associated with Lipegfilgrastim01 Nov 2023Clinical lymphoma, myeloma & leukemia
Loss of CD34+ Cells and Effect of the Number of Viable Cryopreserved CD34+ Cells in the Infused Blood Grafts on Hematologic Recovery, Progression-Free Survival and Overall Survival in NHL Patients After Autologous Stem Cell Transplantation
Article
Author: Pelkonen, Jukka ; Kuitunen, Hanne ; Valtola, Jaakko ; Jantunen, Esa ; Kuittinen, Outi ; Vasala, Kaija ; Turunen, Antti ; Partanen, Anu ; Penttilä, Karri ; Kuittinen, Taru ; Pyörälä, Marja ; Varmavuo, Ville ; Mäntymaa, Pentti
PATIENTS:
This post-hoc study aimed to find out factors affecting graft viable CD34+ cell loss during processing and cryopreservation in 129 non-Hodgkin lymphoma (NHL) patients receiving autologous stem cell transplantation (auto-SCT) and the impact of a low (< 2.0 × 106/kg, group A) and a decent number (≥ 2 × 106/kg, group B) of viable CD34+ cells infused on the hematologic recovery, progression-free survival (PFS) and overall survival (OS) after auto-SCT.
RESULTS:
The median loss of viable CD34+ cells during cryopreservation was higher in group A (47% vs. 19%, p < .001). A higher yield of CD34+ cells at the first apheresis in group B (p = .002) was linked with greater loss of viable graft CD34+ cells after cryopreservation. Filgrastim (FIL) use for mobilization seemed to associate with higher viable CD34+ cell loss compared to pegfilgrastim (PEG) or lipegfilgrastim (LIPEG) in both groups (in group A FIL 66 vs. PEG 35%, p = .006; in group B FIL 37 vs. PEG 15 vs. LIPEG 13%, p < .001). Hematologic recovery after auto-SCT was faster in group B. Neither viable CD34+ cell loss during storage nor viable CD34+ cell number < 2.0 × 106/kg infused affected on PFS or OS.
CONCLUSIONS:
G-CSF type used in mobilization and mobilization capacity were found to correlate with viable CD34+ cell loss during processing and storage. Most importantly, low infused viable CD34+ cell count did not seem to impact on PFS or OS.
01 Jan 2023Cancer control : journal of the Moffitt Cancer Center
Outcome and Cost-Effectiveness Analysis of Long-acting G-CSF as Primary Prophylaxis of Neutropenia Induced by Chemotherapy in Breast Cancer Patients, From a Retrospective Study
Article
Author: Ma, Peizhi ; Jiang, Dandan ; Zhao, Chenglong ; Wang, Yaqin
Purpose:
This retrospective analysis aimed to evaluate the clinical outcomes and cost-effectiveness of long-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia caused by chemotherapy for breast cancer.
Methods:
Patients with breast cancer who received long- or short-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia were enrolled in this study, and incidences of neutropenia were compared between two groups. A decision-analytic and a Markov model were used to compare the health benefits and costs of utilizing long- vs short-acting granulocyte-colony stimulating factor as the primary prophylaxis from the perspective of the Chinese health service system. Subsequently, one-way deterministic and probabilistic sensitivity analyses were conducted. The incremental cost-effectiveness ratios were calculated in baseline and sensitivity analyses.
Results:
Patients receiving long-acting granulocyte-colony stimulating factor as the primary prophylaxis of chemotherapy-induced neutropenia experienced a significant lower incidence of this adverse event, compared with the short-acting one for 2 to 7 days. The outcomes of baseline analysis indicated that long-acting granulocyte-colony stimulating factor had a gain of 0.08 quality-adjusted life years and costed $149 more than the short-acting one, yielding an incremental cost-effectiveness ratio of $1792 per quality-adjusted life year. The sensitivity analysis proved the stability of our models and economic efficiency of long-acting granulocyte-colony stimulating factor.
Conclusions:
Patients receiving long-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia experienced lower risk of this event compared with those underusing short-acting one. The long-acting granulocyte-colony stimulating factor may be a more cost-effective strategy for primary prophylaxis of neutropenia than short-acting one, considering the Chinese willingness-to-pay threshold of $12158.6 per quality-adjusted life year.
02 Dec 2022Current medical research and opinion
Prophylaxis of chemotherapy-induced neutropenia with lipegfilgrastim in patients with lung cancer: final results from the non-interventional study NADIR
Article
Author: Weide, Rudolf ; Losem, Christoph ; Schulz, Holger ; Hipp, Joachim ; Niemeier, Beate ; Fietz, Thomas ; Matillon, Christiane D. ; Frost, Nikolaj ; Potthoff, Karin ; Geßner, Christian ; Grebhardt, Sina ; Eschenburg, Henning ; Kretzschmar, Albrecht ; Lück, Andreas ; Groschek, Matthias ; Harde, Johanna
OBJECTIVE:
Real-world evidence on the application of the granulocyte colony-stimulating factor lipegfilgrastim for the reduction of chemotherapy-induced neutropenia and febrile neutropenia (FN) is limited. The NADIR study aimed to evaluate effectiveness and safety of lipegfilgrastim as primary or secondary prophylaxis in patients with lung cancer undergoing chemotherapy in routine clinical practice.
METHODS:
The non-interventional study NADIR (German Clinical Trials Register (DRKS) Number DRKS00005711) enrolled 156 patients with small-cell lung cancer (SCLC) and 145 patients with non-small-cell lung cancer (NSCLC), who received lipegfilgrastim during chemotherapy. Primary endpoint was the incidence of severe neutropenia (CTCAE grade 3/4) and FN. The analysis was stratified for age groups (≤65 years vs. >65 years).
RESULTS:
Approximately half of the patients were aged >65 years (SCLC 54.5%; NSCLC 46.9%). Intention of antineoplastic treatment was mostly palliative (SCLC 89.1%; NSCLC 73.1%). Patients with high FN risk (SCLC 44.9%; NSCLC 28.3%) mostly received lipegfilgrastim for primary prophylaxis (SCLC 81.4%; NSCLC 70.7%). FN was reported in 1.9% SCLC and 1.4% NSCLC patients. At least one severe neutropenia was documented in 30.1% SCLC and 17.9% NSCLC patients. For NSCLC patients aged >65 years, less severe neutropenia was reported as compared to younger patients (14.7% vs. 20.8%). Lipegfilgrastim-related adverse events were reported in 10.3% SCLC and 7.7% NSCLC patients.
CONCLUSION:
Lipegfilgrastim in routine clinical practice of patients with lung cancer showed similar effectiveness and safety as compared to the pivotal trial. Interestingly, in older patients severe neutropenia was reported less frequently. While most patients with high FN risk received lipegfilgrastim for primary prophylaxis as recommended, there are still 20-30% of patients at high FN risk without primary prophylaxis who could benefit from better adherence to guidelines.
100 Deals associated with Lipegfilgrastim
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10242 | Lipegfilgrastim |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Febrile Neutropenia | European Union | 25 Jul 2013 | |
| Febrile Neutropenia | Iceland | 25 Jul 2013 | |
| Febrile Neutropenia | Liechtenstein | 25 Jul 2013 | |
| Febrile Neutropenia | Norway | 25 Jul 2013 | |
| Neutropenia | European Union | 25 Jul 2013 | |
| Neutropenia | Iceland | 25 Jul 2013 | |
| Neutropenia | Liechtenstein | 25 Jul 2013 | |
| Neutropenia | Norway | 25 Jul 2013 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Peripheral Primitive Neuroectodermal Tumors | Phase 1 | Bulgaria | 01 Jul 2012 | |
| Peripheral Primitive Neuroectodermal Tumors | Phase 1 | Czechia | 01 Jul 2012 | |
| Peripheral Primitive Neuroectodermal Tumors | Phase 1 | Hungary | 01 Jul 2012 | |
| Peripheral Primitive Neuroectodermal Tumors | Phase 1 | Poland | 01 Jul 2012 | |
| Peripheral Primitive Neuroectodermal Tumors | Phase 1 | Russia | 01 Jul 2012 | |
| Peripheral Primitive Neuroectodermal Tumors | Phase 1 | Ukraine | 01 Jul 2012 | |
| Rhabdomyosarcoma | Phase 1 | Bulgaria | 01 Jul 2012 | |
| Rhabdomyosarcoma | Phase 1 | Czechia | 01 Jul 2012 | |
| Rhabdomyosarcoma | Phase 1 | Hungary | 01 Jul 2012 | |
| Rhabdomyosarcoma | Phase 1 | Poland | 01 Jul 2012 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Not Applicable | 104 | Pegfilgrastim 6 mg | mozgybcvib(klbolvgnza) = svcghvvnsl eyaksogcfz (pofacuuzhb ) View more | - | 29 Aug 2020 | ||
mozgybcvib(klbolvgnza) = abrieyrvxy eyaksogcfz (pofacuuzhb ) View more | |||||||
Not Applicable | 328 | fucxamuyke(ocauloownr) = ibzcxulomx xybxzaoeog (nkdlwjwsey ) View more | - | 28 Sep 2019 | |||
Phase 1/2 | 24 | hvjwlucfrn(kxtwhmazsw) = 13% xktyurphzs (jdkuznnwlk ) View more | - | 15 Jun 2019 | |||
Not Applicable | - | embwoocvyh(msslbwtktq) = aqnntrpfjl vokljeozki (fkyhzezcxa ) View more | Positive | 22 Oct 2018 | |||
Not Applicable | 249 | qomacmzyyo(uwialxwvhl) = pmmyxczivk rbpzfalgbk (ehvdgzdymy ) View more | Positive | 18 May 2017 | |||
Phase 1 | 21 | chemotherapy+lipegfilgrastim | wwndtvvnvq(vyscpsncry) = 57% of patients; febrile neutropenia, leukopenia, neutropenia, and thrombocytopenia kqsmjsjetp (zyznjoxnkg ) | Positive | 01 Jan 2017 | ||
Not Applicable | - | bkhroqdcxt(afgrrdcklx) = ralaidrrxp ohnmtoehso (twskmjfcaw ) View more | Positive | 20 May 2012 | |||
Pegfilgrastim 6 mg | bkhroqdcxt(afgrrdcklx) = gbeerbxtpm ohnmtoehso (twskmjfcaw ) View more | ||||||
Not Applicable | 208 | lqlociwkbg(ktsbvqgihg) = wqnfopwzqd xotjqfkcil (crqojvjfdc ) | Positive | 20 May 2011 | |||
lqlociwkbg(ktsbvqgihg) = bqabuxcqkg xotjqfkcil (crqojvjfdc ) |
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