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PE

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

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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PubMedJCO global oncology2026-08-20

Accelerated Methotrexate, Vinblastine, Doxorubicin, and Cisplatin for Muscle-Invasive Bladder Cancer: Real-World Feasibility and Safety in a Resource-Constrained Setting.

Sundriyal Deepak D, Prasath Sai S, Prakash Harsha S HS, Swamy Anusha Mruthyunjaya AM et al.

Muscle-invasive bladder carcinoma (MIBC) poses major treatment challenges in low- and middle-income countries because of logistical and socioeconomic barriers limiting neoadjuvant chemotherapy (NAC) delivery. While dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) improves pathologic response and survival over gemcitabine-cisplatin, its multiday schedule reduces practicality. Accelerated MVAC (AMVAC), a single-day outpatient regimen, may offer a feasible alternative. This study evaluated the feasibility and safety of AMVAC in Indian patients with MIBC. We conducted a single-arm feasibility study at the All India Institute of Medical Sciences, Rishikesh, India, between December 2021 and November 2024. Adults with stage II-III MIBC and cisplatin eligibility received 3-4 cycles of single-day AMVAC with pegfilgrastim support before radical cystectomy. Feasibility was defined as completion of ≥3 or 4 cycles within protocol-specified timeframes. Toxicities were graded using CTCAE v5.0, and outcomes were analyzed descriptively. Sixty patients were enrolled (mean age 55.2 ± 11.2 years; 90% male); 55 received neoadjuvant, and five adjuvant therapy. The mean number of chemotherapy cycles delivered was 3.87 ± 0.85. Feasibility outcomes were favorable, with 91.6% completing three and 76.6% completing four cycles within protocol timelines. Dose reductions for grade ≥3 toxicities were required in 13 patients (21.7%), whereas four patients discontinued treatment because of reduced creatinine clearance. Grade 3 adverse events occurred in 38.3%, most commonly anemia (16.7%), fatigue, and mucositis (13.3% each). Among neoadjuvant recipients undergoing cystectomy (n = 40), pathologic complete response (PCR) was achieved in 32.5% and pathologic downstaging was achieved in 55%. Single-day AMVAC is a feasible and tolerable NAC regimen in a resource-constrained setting, with encouraging PCR and manageable toxicity.

PMID 42623591
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PubMedBreast cancer (Tokyo, Japan)2026-08-14

Risk of febrile neutropenia in breast cancer chemotherapy despite the prophylactic use of pegfilgrastim: a retrospective analysis.

Kusama Hiroki H, Horimoto Yoshiya Y, Iwai Kyoko K, Kitaoku Yuki Y et al.

Pegfilgrastim, a long-acting granulocyte colony-stimulating factor (G-CSF), is used to prevent febrile neutropenia (FN) in breast cancer patients undergoing chemotherapy. However, a small subset of patients still develops FN. This study aimed to assess the real-world incidence of FN and identify potential risk factors in this specific population. This retrospective study included breast cancer patients who received pegfilgrastim prophylaxis at Tokyo Medical University Hospital between February 2019 and December 2024. Inclusion required pegfilgrastim use at least once during chemotherapy. FN was defined as an absolute neutrophil count below 500/µL (or a predicted ANC below 1,000/µL) and an axillary temperature 37.5 °C or higher. Cases of FN and associated risk factors were analyzed using logistic regression models. This study included 378 patients (median age 53). Tumor subtypes were luminal (50.0%), HER2-positive (20.9%), and triple-negative (29.1%), with dose-dense regimens being the most common (55.8%). Of 2,784 total chemotherapy administrations, pegfilgrastim was used in 2,125 cycles (76.3%). The incidence of FN despite pegfilgrastim was 2.1% (8/378), with the highest rate observed in immune checkpoint inhibitor-containing regimens (9.1%, 2/22). Multivariate analysis identified a low baseline platelet count as a significant independent risk factor for combined FN and grade 3-4 neutropenia (OR: 0.98; 95% CI: 0.96-0.99; P = 0.02). Although pegfilgrastim is effective, FN still occurs in a small percentage of patients. A low baseline platelet count was associated with an increased risk of FN or severe neutropenia despite pegfilgrastim prophylaxis, though this finding requires confirmation in larger studies given the limited number of events.

PMID 42599616
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PubMedJMA journal2026-08-11

Efficacy of Early Pegfilgrastim Administration during Preoperative Docetaxel, Cisplatin, and 5-Fluorouracil Therapy in Esophageal Cancer.

Takei Masahiro M, Tsujimoto Hironori H, Ide Asuma A, Kariya Risa R et al.

Docetaxel, cisplatin, and 5-fluorouracil (DCF) therapy is the standard preoperative chemotherapy for advanced esophageal cancer. Although pegfilgrastim (PEG) is used for prophylaxis, the optimal timing remains unclear. This study aimed to evaluate the safety and efficacy of early PEG administration in DCF therapy. We retrospectively analyzed 50 chemotherapy cycles in 28 patients who underwent preoperative DCF therapy. The patients were divided into two groups based on the timing of PEG administration: day 3 (Early group) and day 7 (Late group). We compared hematologic and nonhematologic toxicities between the groups. Early PEG administration significantly reduced leukopenia (Early group vs. Late group: 14% vs. 64%) and neutropenia (21% vs. 79%) and was associated with a lower incidence of febrile neutropenia (7% vs. 36%). Early PEG administration also reduced the incidence of grade ≥3 diarrhea and anorexia and improved food oral intake, weight loss, hyponatremia, and anorexia. Early administration of PEG on day 3 during preoperative DCF therapy for esophageal cancer significantly reduced severe neutropenia and was associated with improved treatment tolerability compared to standard day 7 administration. These findings suggest that early PEG administration is a safe and effective strategy to enhance the tolerability of intensive chemotherapy.

PMID 42576986
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PubMedIJU case reports2026-08-06

Carboplatin Monotherapy Induced Complete Response in Elderly Metastatic Seminoma and CKD: A Case Report.

Omae Gento G, Kitamura Kosuke K, Muto Satoru S

Cisplatin-based chemotherapy is the standard treatment for metastatic seminoma but may be unsuitable for elderly patients with comorbidities. We report a case of metastatic seminoma with chronic kidney disease (CKD) in an elderly patient successfully treated with carboplatin monotherapy. A 70-year-old man presented with a left testicular tumor and para-aortic lymphadenopathy, causing left-sided hydronephrosis. Radical left high orchiectomy confirmed stage IIC pure seminoma pT1N3M0 with a favorable prognosis according to the International Germ Cell Cancer Collaborative Group classification. Because renal impairment and poor performance status precluded cisplatin-based chemotherapy, the patient received four cycles of carboplatin monotherapy (AUC 7). Grade 2-3 pancytopenia occurred but was manageable with pegfilgrastim and dose interval adjustment. Post-treatment PET-CT showed no residual uptake. Consolidation para-aortic radiotherapy was subsequently performed. The patient remains disease-free 1.5 years after treatment. Carboplatin monotherapy may be a feasible alternative for metastatic seminoma patients who are unsuitable for cisplatin-based chemotherapy.

PMID 42559124
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