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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

PubMedCancer treatment and research communications2026-06-03

Pegfilgrastim versus filgrastim for chemo-mobilized stem cell collection in multiple myeloma: A retrospective real-world study.

Zhang Yan-Lin YL, Qin Xin-Yi XY, Cao Chun C, Luo Zhi-Ming ZM et al.

Autologous stem cell transplantation (ASCT) is a standard treatment for newly diagnosed multiple myeloma (MM). Achieving sufficient stem cell yield via effective mobilization promotes successful hematological reconstitution. However, clinical evidence regarding the comparative outcomes of pegfilgrastim (PEG) versus filgrastim (FIL) remains controversial, lacking regimen-specific comparisons. To evaluate the efficacy, safety, efficiency, and costs of PEG versus FIL in MM patients, and compare the impact of cyclophosphamide-based chemo-mobilization on these outcomes. This single-center retrospective study included 102 MM patients (PEG: n = 49; FIL: n = 53). Primary endpoints were CD34⁺ cell yield, mobilization success, duration, and time to engraftment. Statistical analyses included propensity score matching (PSM), overlap weighting (OW), and subgroup analysis. In the overall cohort, PEG and FIL showed equivalent median CD34⁺ yields (3.90 vs. 4.99 × 10⁶/kg, P = 0.096), mobilization success rates, and total hospitalization costs (P = 0.53). FIL yielded a higher total mononuclear cell count (P < 0.001). Subgroup analysis revealed PEG reduced mobilization duration (10 vs. 15 days, P < 0.001) and sessions in chemo-mobilization. PSM showed comparable yields and engraftment. To address PSM sample attrition and balance covariates, OW was utilized, further confirming that PEG significantly shortened overall duration (P = 0.04) and reduced sessions (P = 0.02). Both regimens exhibited similar engraftment kinetics and safety. Both PEG and FIL demonstrate equivalent efficacy for stem cell mobilization in MM. PEG offers superior efficiency by shortening duration and reducing sessions without increasing the total economic burden.

PMID 42229263
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PubMedZhongguo shi yan xue ye xue za zhi2026-06-02

[Efficacy and Safety of Mecapegfilgrastim versus rhG-CSF for Peripheral Blood Stem Cell Mobilization in Healthy Donors: A Comparative Study].

Tang Liu L, Chen Yan Y, Zuo Xiu-Qin XQ, Xing Hong-Yun HY et al.

To compare the efficacy, safety, and pharmacoeconomic differences between Mecapeg-filgrastim and recombinant human granulocyte colony-stimulating factor （rhG-CSF） in mobilizing peripheral blood stem cells （PBSCs） from healthy donors. A total of 100 healthy donors who underwent PBSC mobilization at our center between January 2022 and June 2025 were included and assigned to the Mecapegfilgrastim group or the rhG-CSF group. Successful mobilization was defined as CD34+cells ≥2×106/kg, and optimal mobilization as ≥5×106/kg. The mobilization efficacy, adverse events, and medical costs between the two groups were compared. Outcomes of the corresponding recipients were evaluated, including the dose of infused cells, the time to hematopoietic recovery, and the incidence of acute graft-versus-host disease（aGVHD）. The mobilization success rate was 100% in both groups. The optimal mobilization rate （98.0% vs. 80.0%, P=0.004） and median number of mobilized CD34+ cells ［7.84（4.86-20.86） vs. 5.85（2.99-15.20）×106/kg, P<0.001］ in the mecapeg-filgrastim group were significantly higher than that in the rhG-CSF group, while the number of mononuclear cells was lower ［10.13（5.38-24.80） vs. 12.16（4.99-28.38） × 108/kg, P=0.049］. The engraftment rates of the two groups of recipients （88% vs. 90%） and aGVHD incidence rates （52.3% vs. 48.9%） showed no significant differences（P>0.05）. However, compared with the rhG-CSF group, the Mecapegfilgrastim group showed significantly shorter neutrophil （14 vs. 16 days） and platelet （13 vs. 22 days） engraftment time （both P<0.001）. The incidence and spectrum of adverse events were comparable between the two groups, with no statistically significant difference（32.0% vs.30.0%, P>0.05）. Additionally, compared with the rhG-CSF group, the Mecapegfilgrastim group had a shorter donor hospitalization length ［2（2-3） vs. 6（6-7）days］ and lower mobilization costs（both P<0.001）. In healthy donor PBSC mobilization, Mecapegfilgrastim is non-inferior to rhG-CSF, offers superior promotion of hematopoietic recovery in recipients, and provides significant advantages in reducing hospital stay and medical costs with a comparable safety profile. Mecapegfilgrastim thus represents a more cost-effective mobilization strategy.

PMID 42227452
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PubMedCureus2026-06-01

Rare Invasive Fusarium Sinusitis in a Transiently Immunosuppressed Patient.

Archibald Vincent L VL, Meenrajan Senthil R SR, Schain Denise D, Tishena Anastasia A et al.

A Florida cattle rancher undergoing treatment for lumbar osteomyelitis presented with severe neutropenia and febrile episodes after being discharged on a seven-week course of intravenous (IV) vancomycin and cefepime. Upon admission, antibiotics were changed, and micafungin and filgrastim were added. Several days later, he had a normalizing absolute neutrophil count (ANC) and improving fevers with an overall good clinical appearance. Discharge seemed near, but he continued to complain of nasal congestion and mild oromaxillary pain. In caution, a CT maxillofacial scan and ENT evaluation were performed that revealed extensive nasal septal necrosis with cultures growing Fusarium suttonianum, prompting treatment with IV liposomal amphotericin, IV voriconazole, and oral terbinafine. Due to reported resistance to FDA-approved antifungals, compassionate use medications were explored. Clinically, he continued to look well and reported minimal symptoms despite the severity of necrosis. The patient responded well to triple antifungal therapy inpatient and continued therapy at home until antifungals were paused due to amphotericin-induced acute kidney injury. He had completed 38/42 days of planned treatment at this point, so the decision was made to hold antifungals (including potential compassionate use medications) until his upcoming ENT debridement. This ENT evaluation then confirmed no residual disease. Continuation of the antifungal regimen and additional compassionate use medications were not pursued, and the patient continued to do well. This case teaches to take the potential hematological complications of many antibiotics seriously and raises further teaching points to consider on the risks and management of rare, rapidly progressing invasive infections such as Fusarium.

PMID 42220831
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PubMedTransfusion2026-05-29

Usefulness of pegfilgrastim for allogeneic peripheral blood stem cell collection from healthy donors.

Shimizu Tomoshige T, Jo Tomoyasu T, Yoshinaga Noriyoshi N, Sakamoto Takashi T et al.

Granulocyte colony-stimulating factor (G-CSF)-based mobilization is essential for peripheral blood stem cell (PBSC) collection for allogeneic transplantation. Conventional daily G-CSF requires repeated dosing and dose adjustment and often necessitates leukapheresis over multiple consecutive days, increasing donor burden. Single-dose pegfilgrastim has emerged as an alternative; however, real-world data on its impact on CD34+ cell collection in healthy donors remain limited. Healthy related or unrelated donors who received either a single dose of pegfilgrastim or daily filgrastim and subsequently underwent PBSC collection at Kyoto University Hospital between July 2014 and September 2025 were included. CD34+ cell harvest outcomes and donor burden were compared. A total of 39 donors were analyzed (20 pegfilgrastim, 19 filgrastim), with comparable baseline characteristics. At the start of leukapheresis, peripheral blood white blood cell counts were significantly higher in the pegfilgrastim group. Pegfilgrastim achieved greater total CD34+ cell yield (median 398.0 × 106 vs. 302.4 × 106 cells, p = .025) and higher yields per 10 L of processed blood (median 407.8 × 106 vs. 302.4 × 106 cells, p = .032). Single-session leukapheresis was more frequent with pegfilgrastim (95.0% vs. 63.2%, p = .002), and the estimated processing time required to collect 2 × 106/kg CD34+ cells was shorter (median 62.7 vs. 111.1 min, p = .040). No severe adverse events were observed. These findings suggest that single-dose pegfilgrastim enables more efficient PBSC collection with reduced donor burden and may represent a practical mobilization strategy in healthy allogeneic donors.

PMID 42212441
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PubMedThe American journal of managed care2026-05-26

Biosimilar adoption and provider performance in Medicare value-based payment models.

Chaudhry Basit B, Yue Andrew A, Shelbaya Ahmed A, Tran Lisa L et al.

To quantify the impact of biosimilar adoption on oncology provider financial risk under the Oncology Care Model (OCM) using real-world data. Retrospective study of Medicare fee-for-service beneficiaries potentially eligible for an OCM episode of care initiating between January 2019 and June 2021. Cancer treatment episodes were identified from the Medicare 5% Limited Data Set (LDS). The study sample consisted of episodes with use of any of the following agents or their biosimilars: bevacizumab, rituximab, trastuzumab, epoetin alfa, filgrastim, and pegfilgrastim. Financial risk was defined as the difference in observed total cost of care vs OCM benchmark episode cost. The primary outcome was the difference in financial risk (expressed in nominal US$) under observed use of reference agents and/or biosimilars vs hypothetical use of 100% reference product. The sample included 8851 episodes. Biosimilar adoption resulted in a mean cost reduction of $1023 per 6-month episode vs hypothetical 100% use of reference agents. Biosimilar use increased markedly over the study horizon-with use in 65% of episodes initiating in half 1 (H1) of 2021. The mean cost of care reduction in episodes initiating in H1 2021 ($2060; 4.1% of mean episode benchmark price) improved nearly 10-fold vs H1 2019 ($201; 0.4% of mean episode benchmark price). Rapid adoption of biosimilars for Medicare beneficiaries included in the LDS led to substantial cost savings for cancer episodes evaluated under the OCM methods-suggesting that adoption of biosimilars is a key strategy that providers should consider to manage financial risk in value-based payment models.

PMID 42189077
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PubMedCureus2026-05-15

Pancytopenia and Methemoglobinemia in a Patient With Multiple Myeloma Presenting With Syncope and Dyspnoea: A Diagnostic Challenge.

Abdallah Akram A, Honeini Rawan R, Tamang Pemba P, Abughazal Mahmoud M et al.

Methemoglobinaemia is a rare but important cause of hypoxia that may be overlooked, particularly in patients with complex comorbidities. We present a 76-year-old man with Multiple Myeloma undergoing chemotherapy who presented with recurrent syncope and exertional dyspnoea. Initial investigations revealed pancytopenia and hypoxia. Imaging excluded pulmonary embolism and infection. Arterial blood gas analysis demonstrated elevated methemoglobin levels (10.5%), confirming methemoglobinaemia. The patient was managed with supportive therapy, including oxygen, blood transfusion, and filgrastim, resulting in clinical improvement. This case highlights the importance of considering methemoglobinaemia in patients with unexplained hypoxia, especially when conventional investigations are unremarkable. The coexistence of severe anaemia can further exacerbate tissue hypoxia and complicate diagnosis.

PMID 42137699
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