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filgrastim (Grastofil)

✓ Approved

Apobiologix · CSF3R · Recombinant Proteins

What is filgrastim?

filgrastim is a recombinant proteins developed by Apobiologix. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesGrastofil
CompanyApobiologix
Drug ClassRecombinant Proteins
Molecular TargetCSF3R
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Apobiologix

Mechanism of Action

Molecular Targets

filgrastim acts on 1 molecular target:

CSF3Rcolony stimulating factor 3 receptor (CD114, GCSFR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

filgrastim is developed for 3 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersNeutropenia✓ Approved
Surgical and medical proceduresHaematopoietic stem cell mobilisation✓ Approved
Blood and lymphatic system disordersBone marrow disorder✓ Approved

Related Research Articles

PubMedJournal of orthopaedic science : official journal of the Japanese Orthopaedic Association2026-09-17

Efficacy of prophylactic pegfilgrastim compared with therapeutic filgrastim for preventing febrile neutropenia during chemotherapy for musculoskeletal tumors: A single-center retrospective study.

Tanaka Takaaki T, Nakajima Hideaki H, Imura Yoshinori Y, Wakamatsu Toru T et al.

Febrile neutropenia (FN) is a serious adverse event of chemotherapy that can lead to treatment delays, dose reductions, and life-threatening infections. Prophylactic pegylated granulocyte colony-stimulating factor (peg G-CSF; pegfilgrastim) is recommended to reduce FN risk; however, evidence in patients with musculoskeletal tumors receiving diverse chemotherapy regimens remains limited. We retrospectively reviewed 20 patients (104 chemotherapy administrations) with musculoskeletal tumors treated at a single institution between May 2014 and April 2017. Each patient had received at least one cycle of the same regimen with therapeutic filgrastim prior to switching to prophylactic pegfilgrastim, allowing a within-patient comparison. FN incidence and grade 3/4 neutropenia incidence were compared between the filgrastim group (53 administrations) and the pegfilgrastim group (51 administrations) using Fisher's exact test. FN incidence was significantly lower in the pegfilgrastim group (7.8% vs. 26.4%; odds ratio 0.24, 95% CI 0.07-0.78; P = 0.018), as was grade 3/4 neutropenia (60.8% vs. 100%; P < 0.001). In subgroup analyses by regimen, FN was numerically reduced across all regimens but did not reach statistical significance in any individual subgroup, likely owing to limited statistical power. By diagnosis, FN was significantly reduced in osteosarcoma (P = 0.045) but did not reach significance in other diagnostic subgroups. No significant differences were observed in chemotherapy dose intensity, number of cycles, or length of hospital stay. Prophylactic pegfilgrastim significantly reduced FN and severe neutropenia compared with therapeutic filgrastim in musculoskeletal tumor chemotherapy, suggesting that it may offer a clinically meaningful benefit in this patient population and warranting further prospective investigation.

PMID 42754481
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PubMedClinical kidney journal2026-09-08

Crescentic transformation induced by granulocyte-colony stimulating factor administration-a case report and review of the literature.

Seshadri Hariharan H, Falahat Yassmin Y, Abdelrahim Waseem W, Geng Yimin Y et al.

The use of recombinant human granulocyte-colony stimulating factor (G-CSF) is an uncommon aetiology for acute kidney injury in cancer patients. Several patterns of renal injury due to G-CSF have been discussed in the literature. Here, we present a case of a 48-year-old man with monoclonal gammopathy of renal significance who received filgrastim for planned autologous stem cell transplantation and developed acute kidney injury presenting as crescentic glomerulonephritis. The patient was treated with steroids, plasmapheresis, and cyclophosphamide. He attained complete recovery and proceeded with stem cell transplantation. We conducted an extensive review of the literature on the subject, which revealed that 10 of the 18 biopsy-proven cases of G-CSF-induced renal injury presented as crescentic glomerulonephritis. When G-CSF is administered to patients with an underlying renal pathology (usually autoimmune or monoclonal in aetiology), the migration and degranulation of activated neutrophils in the glomerular microenvironment in large numbers results in glomerular basement membrane rupture and crescent formation. Timely renal biopsy and aggressive initiation of treatment aid in attaining renal recovery and a favourable prognosis in cancer patients.

PMID 42708005
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PubMedRecenti progressi in medicina2026-09-03

[Efficacy and safety of sacituzumab govitecan in patients with metastatic HR+/HER2- pleomorphic lobular breast cancer complicated by renal impairment.]

Martinelli Claudia C

The case concerns a 68-year-old female patient with metastatic HR-positive/HER2-negative pleomorphic lobular breast carcinoma and severe chronic renal impairment since diagnosis, previously treated with multiple lines of therapy. At diagnosis in September 2021, the disease was already metastatic, with bone, nodal, and pleural involvement. The patient received endocrine therapy with CDK4/6 inhibitors, chemotherapy, and targeted agents, with subsequent multiorgan progression. The clinical course was further complicated by persistent severe renal impairment requiring urinary diversion procedures prior to sacituzumab govitecan initiation. In November 2025, the patient experienced multiorgan progression and clinical deterioration (ECOG PS 2), including ascites, peripheral edema, dyspnea, and anorexia. Following multidisciplinary evaluation, sacituzumab govitecan was initiated in December 2025 at full dose (10 mg/kg), with primary prophylaxis using filgrastim. During the first cycle, worsening renal function and grade 2 toxicity occurred, leading to omission of day 8 administration. Treatment was subsequently resumed at a reduced dose (7.5 mg/kg), achieving good tolerability, stabilization of renal function, and clinical benefit. At reassessment in March 2026, a partial response was documented. The patient is currently continuing treatment with overall good tolerability. This case highlights the feasibility of a personalized approach with sacituzumab govitecan in frail patients with severe renal impairment and lobular breast cancer, populations underrepresented in clinical trials.

PMID 42684174
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PubMedJCO global oncology2026-08-20

Clinical Implications and Prevalence of Duffy-Null Associated Neutrophil Count in Patients With Breast Cancer of Middle Eastern Ethnicity.

Prem Sudha Shruti S, Abdelfattah Nabil M NM, Yetisyigit Tarkan T, Najeebi Taif T et al.

Duffy-null associated neutrophil count (DANC), formerly known as benign ethnic neutropenia, is seen in people of African and Middle Eastern descent and does not represent a true neutropenic state. Individuals with DANC can be identified by the Duffy-null phenotype on red cells. There is evidence that cancer patients with DANC are not at an increased risk of infection with chemotherapy. The aims of this study were to assess the prevalence of DANC among patients with breast cancer of Middle Eastern ethnicity and to study treatment delays, infectious complications, and survival in these patients. We retrospectively reviewed 493 patients with breast cancer treated in a referral oncology center in Bahrain. Patients with neutropenia or leukopenia at presentation with Duffy-null phenotype and no identifiable secondary causes of neutropenia were presumed to have DANC. Clinical details studied included treatment delays, filgrastim responsiveness, and episodes of febrile neutropenia. A contemporaneous group of patients with breast cancer without DANC were used for comparison. Seventy-two patients (14.6%) had a presumed diagnosis of DANC, and the median neutrophil count at presentation was 1.2 × 103/µL (range, 0.4-2.1 × 103/µL). Treatment delays and discontinuations were significantly more common in patients with DANC (P < .001) and were not decreased by prophylactic filgrastim use. Patients with DANC were uniformly filgrastim responsive, and only one patient had neutropenic fever. There was no effect of treatment delay or DANC on OS or PFS. DANC is prevalent among patients with breast cancer in Bahrain, and Duffy phenotyping on red cells can be a surrogate marker for diagnosis. Treatment delays because of the apparent neutropenia are common in DANC; however, febrile neutropenia is uncommon. This study is of particular relevance in populations with a high prevalence of DANC.

PMID 42623593
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PubMedCureus2026-08-20

Cryptococcal Meningitis Revealing Late-Onset Combined Immunodeficiency After Two Decades of Recurrent Infections: A Case Report.

Martínez Evangelista Valeria J VJ, Munoz Plascencia Sandra S, Cárdenas-Favela Juan C JC, Correa Serrano Carlos A CA

Adult-onset inborn errors of immunity pose a significant diagnostic challenge because of their non-specific clinical presentation and frequent delay in diagnosis. We report a case of a 53-year-old woman with a nearly two-decade history of recurrent infections whose clinical course culminated in cryptococcal meningitis, prompting a comprehensive immunologic evaluation. Following the systematic exclusion of secondary causes of immunodeficiency, immunologic testing revealed hypogammaglobulinemia and profound CD4+ T-cell lymphopenia (188 cells/µL), consistent with combined humoral and cellular immune dysfunction and supporting classification within the late-onset combined immunodeficiency (LOCID) phenotype. Following appropriate antifungal therapy, subsequent immunoglobulin replacement therapy and filgrastim were associated with sustained clinical improvement. This case highlights that cryptococcal meningitis in HIV-negative patients should prompt a systematic evaluation for an underlying primary immunodeficiency and underscores the importance of recognizing the LOCID phenotype as an uncommon but potentially treatable cause of opportunistic infections in adults.

PMID 42621176
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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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