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pegfilgrastim (GBS010 / GBS 010)

✓ Approved

Kidswell Bio · CSF3R · Recombinant Proteins

What is pegfilgrastim?

pegfilgrastim is a recombinant proteins developed by Kidswell Bio. It is approved for therapeutic indications via unknown.

Drug Profile

Brand NamesGBS010, GBS 010
CompanyKidswell Bio
Drug ClassRecombinant Proteins
Molecular TargetCSF3R
RouteUnknown
StatusApproved
Sources: ClinicalTrials.gov, Kidswell Bio

Mechanism of Action

Molecular Targets

pegfilgrastim 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

pegfilgrastim is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersBone marrow disorder✓ Approved

Related Research Articles

PubMedJCO oncology practice2026-10-06

Impact of Primary Prophylactic Colony-Stimulating Factor Delivery Method on Febrile Neutropenia: Secondary Analysis of a Pragmatic Cluster Randomized Clinical Trial.

Shih Lauren L, Arnold Kathryn B KB, Bansal Aasthaa A, Bell-Brown Ari A et al.

Primary prophylactic colony-stimulating factor (PP-CSF) is recommended for patients receiving chemotherapy with high risk of febrile neutropenia (FN). The impact of PP-CSF delivery method on FN is unknown. We performed a secondary analysis of SWOG S1415CD (Trial Assessing CSF Prescribing Effectiveness and Risk), a pragmatic, cluster-randomized trial evaluating a guideline-informed standing order system to improve PP-CSF use, to evaluate associations between PP-CSF delivery method and FN. Female patients with breast cancer receiving first-line chemotherapy and PP-CSF with a known delivery method (administration in-clinic [IC], home delivery via an on-body device [OBD], or home self-injection [SI]) were included. The primary outcome was FN within 6 months of chemotherapy initiation, defined per the Common Terminology Criteria for Adverse Events. Among 1,713 patients, the median age was 55 years (IQR, 46-64). By stage, 566 (33%) were local, 709 (41%) regional, 41 (2%) distant, and 397 (23%) unknown. PP-CSF was delivered IC in 773 (45%), OBD in 862 (50%), and SI in 78 (5%). Most received high-risk FN regimens. Pegfilgrastim use was nearly exclusive in IC and OBD (98% and 99%), versus 29% in SI. FN incidence was low: IC 3.8% (95% CI, 2.5 to 5.3), OBD 5.0% (95% CI, 3.6 to 6.6), and SI 6.4% (95% CI, 2.1 to 14.3; P = .29). FN was associated with high-risk FN regimens (odds ratio [OR], 2.97 [95% CI, 1.2 to 9.9]; P = .04) and Zubrod performance status ≥2 (OR, 4.99 [95% CI, 1.12 to 15.9]; P = .01), but not with delivery method or PP-CSF agent. Women with breast cancer receiving chemotherapy and PP-CSF had low rates of FN regardless of PP-CSF delivery method or agent. Delivery decisions may be guided by patient-centered factors including cost, convenience, and access.

PMID 42837634
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PubMedRhode Island medical journal (2013)2026-09-25

Atypical Bullous Sweet Syndrome.

London Jonathan J, Patresan John J, Belkin Alexander A, Elnair Radowan R

Sweet syndrome (acute febrile neutrophilic dermatosis) is characterized by fever, leukocytosis, and tender erythematous skin lesions with neutrophilic infiltrate. Although associated with granulocyte colony-stimulating factor (G-CSF) use, its occurrence with pegfilgrastim-the pegylated form-is rare, with fewer than five reported cases. Sweet syndrome has also been rarely linked to FLT3 inhibitors such as quizartinib. We report a 71-year-old male with acute myeloid leukemia who developed bullous Sweet syndrome following concurrent exposure to pegfilgrastim and quizartinib.

PMID 42789806
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PubMedEuropean journal of cancer (Oxford, England : 1990)2026-09-25

Prophylactic use of G-CSFs to reduce neutropenia rates in patients treated with antibody-drug conjugates: A literature review.

Scotté Florian F, Lustberg Maryam M, Aapro Matti M, Ben Abid Fatma F et al.

Although multiple antibody-drug conjugates (ADCs) have demonstrated sufficient efficacy and safety to warrant their approval, many patients require supportive treatment to reduce the severity of ADC-associated toxicities. Clinical guidelines recommend the use of granulocyte colony-stimulating factors (G‑CSFs), such as filgrastim, lenograstim, and long-acting pegfilgrastim, to reduce the duration and severity of chemotherapy-induced neutropenia and the risk of febrile neutropenia (FN). The objective of this literature review was to summarize the available data on the use of G-CSFs in patients treated with ADCs as a strategy to mitigate the risk of severe neutropenia and FN. The identified literature highlight the importance of prophylactic G-CSF use to reduce the occurrence of FN and severe neutropenia in patients treated with ADCs. Although data evaluating the effect of G-CSF use as secondary prophylaxis are limited, available studies highlight the clinical necessity of mitigating neutropenia risk associated with ADCs.

PMID 42790204
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PubMedBMJ case reports2026-09-24

Anaphylaxis to both pegfilgrastim and sargramostim in a patient with diffuse large B-cell lymphoma.

Khamis Mohamed M MM, Finnie John W JW

A woman in her early 60s with stage 3A diffuse large B-cell lymphoma developed anaphylaxis to pegfilgrastim after her first cycle of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) chemotherapy, presenting with syncope, severe diarrhoea and persistent hypotension requiring hospitalisation. Three further cycles were given without growth factor support. After cycle four she developed neutropenic fever and received sargramostim (granulocyte-macrophage colony-stimulating factor) under intensive premedication and intensive care monitoring, which she initially tolerated; on the third administration she developed anaphylaxis requiring epinephrine. She completed all six cycles of R-CHOP without growth factor support, using prophylactic antibiotics and close monitoring, achieved complete remission and remains disease-free 41 months after treatment. To our knowledge, this is the second documented case of anaphylaxis to agents from both the granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor classes in one patient, and the first involving pegfilgrastim.

PMID 42785762
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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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PubMedAdvances in urology2026-09-13

Neutropenia in Patients With Castration-Resistant Prostate Cancer Treated Using Cabazitaxel and Prophylactic Administration of Pegfilgrastim.

Oshinomi Kazuhiko K, Kikuchi Shota S, Kurokawa Masahiro M, Mugita Toshiki T et al.

Cabazitaxel has demonstrated survival benefits in patients with metastatic castration-resistant prostate cancer (CRPC). However, Japanese patients are reported to experience higher rates of hematologic toxicity compared to their Caucasian counterparts. Although primary prophylaxis with pegfilgrastim is now routinely used in clinical practice, febrile neutropenia (FN) may still occur. In this study, we aimed to evaluate the real-world safety of cabazitaxel with universal pegfilgrastim prophylaxis in Japanese patients with CRPC, particularly focusing on FN during the first treatment cycle. We retrospectively evaluated 86 patients with CRPC who received cabazitaxel at Showa Medical University-affiliated hospitals between 2015 and 2021. Cabazitaxel was administered every 3-4 weeks at doses determined by the treating physicians, generally 20-25 mg/m2, with daily oral prednisolone. Pegfilgrastim was administered to all patients at least 24 h after cabazitaxel. Univariate analyses were performed to identify baseline factors associated with FN occurring during the first cycle of cabazitaxel. Exploratory logistic regression analysis was additionally performed for FN occurring during the entire treatment course. Among the 86 patients, FN occurred in 12 patients (14.0%) during the entire treatment course, including 8 events (9.3%) during the first cycle. In univariate analyses, the only factor significantly associated with first-cycle FN was a longer interval from CRPC diagnosis to cabazitaxel initiation (median, 1194.5 vs. 689 days, p = 0.0094). A similar tendency was observed when FN occurrence during the entire treatment course was analyzed. In exploratory logistic regression analysis for FN during the entire treatment course, the same factor showed a consistent trend toward association with FN development. Despite universal pegfilgrastim prophylaxis, approximately 10% of Japanese patients developed FN during the first cycle of cabazitaxel therapy. A longer interval from CRPC diagnosis to cabazitaxel initiation showed a consistent trend toward association with FN risk in Japanese patients across analyses. These findings provide real-world safety data and highlight the importance of careful hematologic monitoring, particularly in patients treated later in the CRPC disease course.

PMID 42732376
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