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filgrastim (Grastofil)

✓ Approved

Apobiologix · CSF3R · 重组蛋白

什么是 filgrastim？

filgrastim 是一种重组蛋白，由Apobiologix研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Subcutaneous Injection。

药物档案

商品名Grastofil
公司Apobiologix
药物类别重组蛋白
分子靶点CSF3R
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Apobiologix

作用机制

分子靶点

filgrastim 作用于 1 个分子靶点：

CSF3Rcolony stimulating factor 3 receptor (CD114, GCSFR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

filgrastim 针对 3 个适应症，涉及 2 个治疗领域。

治疗领域疾病/病症分期
Blood and lymphatic system disordersNeutropenia✓ Approved
Surgical and medical proceduresHaematopoietic stem cell mobilisation✓ Approved
Blood and lymphatic system disordersBone marrow disorder✓ Approved

相关研究文献

PubMedHematology, transfusion and cell therapy2026-07-31

Improving engraftment in autologous hematopoietic stem cell transplantation: comparing pegfilgrastim with filgrastim in an outpatient setting.

Gutierrez-Aguirre Cesar Homero CH, la Garza-Salazar Fernando De F, Gómez-Almaguer David D, Jaime-Pérez José Carlos JC et al.

Febrile neutropenia, a frequent complication in patients undergoing autologous stem cell transplantation, increases morbidity and hospitalization costs. The aim of this study was to compare the efficacy of two formulations of pegylated filgrastim with filgrastim in patients who received autologous stem cell transplantation as outpatients for lymphoma or myeloma. Thirty patients were randomized to receive a single 6 mg dose of either reference or biosimilar pegfilgrastim on Day +1. A retrospective Control Group of fifty-three patients who received filgrastim was included. The median times to neutrophil engraftment were 10, 9 and 11 days for the innovator pegfilgrastim, biosimilar pegfilgrastim (p-value = 0.14), and filgrastim (p-value = 0.0001), respectively. The median times to platelet engraftment were 10 days for both of the pegfilgrastim groups and 12 days for the filgrastim group (p-value = 0.0001). Febrile neutropenia incidence was lower in the pegfilgrastim group (6.7%) than in the filgrastim group (24.5%; p-value = 0.04). Cost analysis showed higher costs for the innovator pegfilgrastim, with filgrastim having the lowest cost of the three formulations. The innovator and the biosimilar pegfilgrastim demonstrated similar efficacy in engraftment speed and febrile neutropenia incidence. Pegfilgrastim was associated with faster engraftment, a lower incidence of platelet transfusion, and a lower incidence of febrile neutropenia.

PMID 42531780
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PubMedImmunotherapy advances2026-07-25

Growth factor supportive care for chemotherapy-induced neutropenia suppresses antitumour immunity in checkpoint blockade-responsive pancreatic cancer.

Parent Brendan D BD, Kelly Anthony E AE, Hoffman Megan T MT, Dougan Michael M et al.

Growth factors, including granulocyte colony-stimulating factor (G-CSF; pegfilgrastim, filgrastim), are used for prophylaxis or treatment of chemotherapy-induced neutropenia, yet their effects on antitumour immunity remain incompletely understood. We previously found that serum from patients with pancreatic ductal adenocarcinoma (PDAC) treated with multiagent chemotherapy plus G-CSF drove differentiation of T cell-suppressive monocytes in vitro, suggesting that supportive care interventions may shape immune responses in this disease. We evaluated the immunologic and therapeutic impact of G-CSF in two murine PDAC models that differ in their baseline frequencies of infiltrating T cells and in their responsiveness to checkpoint blockade immunotherapy. In poorly immunogenic, T-cell-low tumours, use of G-CSF did not affect tumour growth or response to chemo- or immunotherapy, although neutrophil recovery was improved in mice receiving FOLFIRINOX and G-CSF compared to chemotherapy alone. In immunogenic tumours with a robust endogenous T-cell response, combination anti-PD1 and anti-CTLA-4 therapy resulted in durable tumour clearance. Combination with G-CSF diminished the effectiveness of checkpoint blockade and resulted in significantly fewer cured mice. G-CSF, commonly used for supportive care with FOLFIRINOX and other chemotherapy regimens, induces systemic immune suppression that can reduce the efficacy of T-cell-targeting immunotherapies.

PMID 42500327
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PubMedLa Revue de medecine interne2026-07-23

[Sustained complete remission achieved with tofacitinib in a refractory T-cell large granular lymphocytic leukemia].

Carré Adèle A, Deshayes Samuel S, Martin-Silva Nicolas N, Comoz François F et al.

Treatment of large granular lymphocytic leukemia, particularly T-cell leukemia (LGL-T), remains challenging. JAK inhibitors, although still scarcely evaluated, appear promising. An 85-year-old woman was treated for a refractory LGL-T associated with neutropenia, unclassified polyarthritis and vitiligo. During the 7-year course of the disease, she received alternatively cyclosporine, cyclophosphamide and methotrexate, associated with prednisone and/or filgrastim. During a severe relapse with agranulocytosis complicated by infectious pneumonia, no response was observed after 14 days of filgrastim. Ten days after initiation of tofacitinib, a marked increase of the neutrophil count (98G/L) occurred, associated with Sweet syndrome. Both resolved rapidly with filgrastim discontinuation. Tofacitinib allowed a rapid and complete remission of both hematological and clinical manifestations, which was maintained throughout 37 months of follow-up. This report adds to the limited evidence supporting tofacitinib in LGL-T and further highlights the potential of JAK-inhibition, particularly in refractory and systemic forms.

PMID 42486736
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PubMedInternational journal of clinical oncology2026-07-23

Efficacy of anti-GD2 antibody immunotherapy with filgrastim and teceleukin versus standard treatment with sargramostim, aldesleukin and isotretinoin in children with high-risk neuroblastoma.

Nitani Chika C, Hara Junichi J, Kawamoto Hiroshi H, Taguchi Tomoaki T et al.

Granulocyte-macrophage colony-stimulating factor (GM-CSF), aldesleukin and isotretinoin are unavailable in Japan, necessitating alternative cytokines for dinutuximab immunotherapy. We compared the efficacy of a regimen containing granulocyte colony-stimulating factor (G-CSF)/teceleukin (regimen A) to that with GM-CSF/aldesleukin/isotretinoin (regimen B) in children with newly diagnosed high-risk neuroblastoma. After completing initial therapy including high-dose chemotherapy followed by autologous stem cell transplantation and radiotherapy, children with non-progressive disease were randomized to regimen A or B. Regimen B was identical to the immunotherapy regimen tested in ANBL0032 (six cycles of isotretinoin and five concomitant cycles of dinutuximab alternating with GM-CSF and aldesleukin). Regimen A consisted of six cycles of dinutuximab alternating with G-CSF and teceleukin. Event-free survival (EFS) and overall survival (OS) were compared between two regimens. In total, 35 patients (16 receiving regimen A and 19 receiving regimen B) were enrolled. The 2-year EFS was 80.8% for patients receiving regimen A and 62.3% for those receiving regimen B, and their OS rates were 93.8% and 100.0%, respectively. The hazard ratio of regimen A compared to regimen B for EFS was 0.494 (upper limit of one-sided 70% confidence interval: 0.710), suggesting comparable efficacy of the two regimens. Frequently recorded grade 3/4 adverse events were fever, infection, and hematologic toxicity with no obvious difference in incidence between the regimens. Our results suggest that the efficacy of the alternative regimen containing G-CSF is comparable to that of the ANBL0032 regimen, providing a rationale for further evaluation in a phase III trial.

PMID 42490004
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PubMedFrontiers in pediatrics2026-07-06

Granulocyte colony-stimulating factor-induced hypersensitivity reaction with leukocytosis in a pediatric germ cell tumor patient: a case report.

Tan Yuhui Y, Wei Chaoyong C, Xiao Wenyan W, Fu Yilan Y et al.

Chemotherapy-induced bone marrow suppression significantly increases the risk of febrile neutropenia (FN) in cancer patients. Granulocyte colony-stimulating factor (G-CSF) is a cornerstone therapy for FN prophylaxis and treatment that promotes myeloid progenitor cell proliferation and differentiation, thereby reducing the duration of neutropenia. While G-CSF is generally well tolerated and has a favorable safety profile, rare but life-threatening adverse events may occur. We present the case of a 14-year-old female with a germ cell tumor who developed a systemic hypersensitivity reaction following prophylactic administration of efbemalenograstim alfa-vuxw (20 mg/dose) after her third chemotherapy cycle. Notably, the patient had previously tolerated two full doses of efbemalenograstim alfa-vuxw and one full dose of short-acting G-CSF (filgrastim biosimilar 5 μg/kg) without any adverse events during the first two chemotherapy cycles. Within two hours post-injection, she exhibited severe hypotension (74/52 mmHg), hypoxemia (SpO₂ 81%), and marked leukocytosis (55.32 → 104.25 × 10⁹/L within 24 h). Emergency intervention with epinephrine and dexamethasone resolved the symptoms. Peripheral blood analysis revealed eosinophilia (0.16 × 10⁹/L), suggesting drug sensitization. During the fourth chemotherapy cycle, subcutaneous recombinant human G-CSF (rhG-CSF, filgrastim biosimilar; 5 μg/kg) was administered, but the patient experienced a nearly identical reaction within 30 min (BP 53/29 mmHg, SpO₂ 97%). The temporal correlation and clinical consistency confirmed a G-CSF-induced systemic hypersensitivity reaction. To our knowledge, this represents the first documented pediatric case of recurrent systemic hypersensitivity reactions induced by sequential administration of different G-CSF formulations following chemotherapy. Notably, long-acting G-CSF (efbemalenograstim alfa-vuxw) was associated with both hypersensitivity and pronounced leukocytosis. Our findings highlight the following: 1. Hypersensitivity to G-CSF, although rare, requires heightened clinical vigilance; 2. The Substitution of G-CSF products may not preclude recurrent reactions; 3. The safety profile and optimal dosing of efbemalenograstim alfa-vuxw in pediatric populations warrant further validation in controlled trials.

PMID 42403385
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PubMedEcancermedicalscience2026-07-02

Establishment of the first bone marrow transplant program in francophone sub-Saharan Africa: clinical case and future perspectives.

Niang Elhadji Daouda ED, Fall Seynabou S, Toure Sokhna Aissatou SA, Camara Marieme Lolita ML et al.

Haematopoietic stem cell transplantation (HSCT) offers curative potential for several malignant and non-malignant hematologic disorders. Despite its proven efficacy, access to HSCT in sub-Saharan Africa remains limited, especially in francophone countries, due to the lack of infrastructure, cryobiology facilities and trained personnel. Senegal recently launched a national initiative to establish its first HSCT program. We report the first autologous HSCT performed in Senegal in February 2025 at Dalal Jamm University Hospital, in a 51-year-old man diagnosed with high-risk IgA-lambda multiple myeloma (ISS stage III, del17p). Mobilisation was achieved using filgrastim (10 µg/kg/day for 7 days). A total of 2.8 × 10⁶ CD34⁺ cells/kg were collected by apheresis and stored at 4°C for 24 hours without cryopreservation. Conditioning consisted of high-dose intravenous melphalan (200 mg/m2) followed by reinfusion of the graft on day 0. Hematologic recovery occurred by day +10, with transient grade 3 anemia and grade 4 thrombocytopenia requiring transfusion support. The main complications were manageable febrile neutropenia and mild gastrointestinal and renal toxicities. The patient was discharged on day +17, remained infection-free and achieved complete hematologic and biochemical remission at five months post-transplant. Consolidation therapy with bortezomib-thalidomide-dexamethasone and lenalidomide maintenance was subsequently administered. This first non-cryopreserved autologous HSCT in Senegal demonstrates the feasibility, safety and cost-effectiveness of transplantation under resource-limited conditions. Establishing local cryopreservation and molecular diagnostic capabilities will be essential to enable tandem and allogeneic HSCT, ensuring sustainability and regional self-sufficiency in advanced hematologic care.

PMID 42389559
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