Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche - LARVOL DELTA

When supportive care backfires: G-CSF induced aortitis unmasked during routine adjuvant chemotherapy (ASH 2025) - "After shared decision-making, patient began monthly adjuvant docetaxel/cyclophosphamide (TC) chemotherapy with G-CSF (Neulasta) support...The patient improved dramatically with Prednisone 60mg once while hospitalized and discharged with a prolonged Prednisone taper... This case highlights how early recognition of rare treatment-related toxicities, even those tied to supportive agents like G-CSF can change the clinical trajectory and spare patients from unnecessary testing or prolonged hospitalization. Embedding red-flag symptom pathways into triage protocols, especially in high-volume cancer centers, is a practical and scalable way to protect care quality. When multidisciplinary teams are empowered with education and diagnostic curiosity, even rare complications don't stand a chance of being missed."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Infectious Disease • Pulmonary Embolism • Respiratory Diseases • Solid Tumor • Vasculitis • ER • HER-2 • PGR

ZAP trial: MRD-guided chemotherapy and maintenance de-escalation with zanubrutinib-g-CHOP in high-risk FL (Phase II) (ASH 2025) - P2 | "Background : Patients with untreated follicular lymphoma (FL) and intermediate-high risk FLIPI scores (≥2)face poor outcomes: 5-year PFS is ~50% with standard G-CHOP plus 2-year obinutuzumab maintenance,accompanied by significant toxicity (infection, cytopenias, secondary malignancies and quality-of-lifedeterioration)...The phase II ZAP (Zanubrutinib-Adapted Protocol) trial pioneers a response-adapted de-escalation paradigm integrating zanubrutinib into frontline therapy, aiming to maximize earlymolecular remissions while reducing treatment burden in this vulnerable population. From April 2024 to December 2024, this phase II trial (NCT06474481) enrolled 32 untreated FLpatients (FLIPI 2-5) receiving 4 cycles of zanubrutinib (160mg BID) + standard G-CHOP with mandatorypegfilgrastim prophylaxis... The ZAP trial demonstrates that zanubrutinib-enhanced G-CHOP induces high CR (84.4%) andMRD negativity (>90%) rates in high-risk FL, enabling early chemotherapy..."

Clinical • P2 data • Atrial Fibrillation • Cardiovascular • Febrile Neutropenia • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia

Etoposide + cytarabine + pegfilgrastim vs cyclophosphamide + granulocyte colony-stimulating factor for stem-cell mobilization in patients with multiple myeloma: A phase III trial (ASH 2025) - P3 | "Theirprevious exposure to lenalidomide (either4 cycles or ≤ 4 cycles) determined this allocation.Intravenousetoposide at 75 mg/m² daily, intravenous cytarabine at 200 mg/m² every 12 hours, and subcutaneouspegfilgrastim at 6 mg on day 6 were the therapies administered to patients in the EAP group on days 1and 2. In comparison to CG, EAP showed better mobilization efficiency, with a greater percentage ofpatients reaching optimal/target HSC collection thresholds in fewer apheresis sessions. There were nounanticipated side effects, and the regimen demonstrated good safety and acceptability. EAP's lowplerixafor requirement emphasizes self-sufficiency and establishes it as a good first-line treatment forMM patients, especially in situations with limited resources where access to plerixafor is restricted orprohibitively expensive."

P3 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Thrombocytopenia • CD34

Use of G-CSF in AML patients with febrile neutropenia: Friend or foe? (ASH 2025) - "Patients were grouped based on whether they received G-CSF(filgrastim or pegfilgrastim) during hospitalization for febrile neutropenia...These findingsnot only support the clinical benefit and long-term safety of G-CSF in this population, but also challengeprevious studies that reported no survival advantage with its use. Further prospective research iswarranted to validate these findings and optimize the role of G-CSF in supportive care protocols forpatients with AML."

Clinical • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Pulmonary Embolism • Respiratory Diseases • TINCR

Etoposide-cytarabine-pegfilgrastim (EAP) and disease-specific chemotherapy regimens for hematopoietic stem cell mobilization in lymphoma: A randomized phase III trial (ASH 2025) - P3 | "Secondary endpoints included: (1) rates of achieving theminimum target (≥2×10⁶ CD34+ cells/kg) and optimal target (≥5×10⁶ CD34+ cells/kg) mobilization; (2)median cumulative CD34+ cell yield; (3) mean number of apheresis sessions required; (4) safety profiles,encompassing adverse event frequency and severity; and (5) rates of plerixafor utilization between thegroups.Between July 2024 and July 2025, 44 patients from 10 sites were randomized to either EAP (n = 30) orcontrol (n = 14). In fewer apheresis sessions, more patients were able to reach ideal HSC collection thresholdsthanks to the EAP regimen's improved mobilization effectiveness and comparable safety. Given themarkedly decreased demand for plerixa for rescue, EAP appears to be a financially sensible mobilizingtechnique for NHL patients."

Clinical • P3 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • CD34

A prospective, multicenter study on stem cell mobilization using EAP regimen as first-line mobilization in patients with multiple myeloma and lymphoma (ASH 2025) - "The EAPregimen comprised etoposide 75 mg/m2/day for two days, cytarabine 200 mg/ m2 twice daily for twodays, and pegfilgrastim 6 mg on day 6. The EAP regimen demonstrates an optimal efficacy and safety profile, making it a promisingalternative for stem cell mobilization in MM and lymphoma, particularly in populations with plerixafor-inaccessible."

Clinical • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Multiple Myeloma • CD34

Phase 2 trial of polatuzumab vedotin, rituximab and dose attenuated CHP in patients 75 years and older with large B-cell lymphoma (ASH 2025) - "Dose attenuated rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-miniCHOP) is an effective, well-tolerated regimen in this population (Peyrade et al, 2011) and isrecommended by guidelines as a standard of care...Pegfilgrastim was required for all pts...While not statistically significant, the increasedCR rate in the non-GCB group is consistent with the previously demonstrated benefit of pola in thispopulation. Additional follow up is required to evaluate the durability of these responses."

Clinical • P2 data • Alopecia • Anorexia • Atrial Fibrillation • B Cell Lymphoma • Cardiovascular • Constipation • Dermatology • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Malignancies • High-grade B-cell lymphoma • Immunology • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of Pegfilgrastim in Patients With Severe Congenital Neutropenia. (PubMed, EJHaem) - "Larger studies are warranted to evaluate its long-term safety and efficacy. This trial is registered at https://irct.behdasht.gov.ir/ in Iranian Registry of Clinical Trials (IRCT) # IRCT20150125020786N3."

Journal • Hematological Disorders • Immunology • Infectious Disease • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Primary Immunodeficiency • CSF3R • RUNX1

Efficacy and safety of telpegfilgrastim in the prevention of neutropenia following chemotherapy for non-myeloid tumors: A retrospective study (ESMO Asia 2025) - "All patients received 2mg of pegfilgrastim 24 hours after chemotherapy drug administration. Telpegfilgrastim holds advantages in preventing CIN, demonstrating favorable efficacy and safety. The incidence of grade 3/4 CIN was only 7.8% and FN was 0%. Telpegfilgrastim also has a long-lasting protective effect of ANC to ensure the normal progress of treatment."

Retrospective data • Chemotherapy-Induced Neutropenia • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor

Successful steroid-sparing management of G-CSF-associated large-vessel vasculitis (ESMO Asia 2025) - "Steroid-sparing management may be a safe and effective approach for G-CSF-associated LVV."

Breast Cancer • Oncology • Solid Tumor

Efbemalenograstim alfa significantly reduces incidence of incidence of severe chemotherapy-induced neutropenia in later cycles: Results of a meta analysis (SABCS 2025) - " ISN rates from four cycles from phase III trials of efbemalenograstim alfa and three different chemotherapy regimens, docetaxel + cyclophosphamide (TC) (Trial 1), epirubicin + cyclophosphamide (EC) (Trial 2), and high myelotoxic docetaxel + doxorubicin (TA) (Trial 3 + historic pegfilgrastim and filgrastim comparative data) were evaluated. Across studies, non-PEGylated efbemalenograstim alfa has demonstrated equivalent or lower incidence rates of severe neutropenia (grade 4, ANC <0.5 × 109/L) during the first cycle of three types of chemotherapy (TC, EC and TA) and importantly, significantly lower rates in later cycles when compared to pegfilgrastim and filgrastim. These findings demonstrate that efbemalenograstim alfa may be more effective at preventing severe, life-threatening neutropenia at later chemotherapy cycles, which has meaningful implications for real-world breast cancer patients that are likely to receive chemotherapy for longer durations."

Retrospective data • Breast Cancer

Long-term safety in breast cancer patients receiving doxorubicin-cyclophosphamide chemotherapy with secondary G-CSF prophylaxis: A single-centre prospective study (SABCS 2025) - "Secondary G-CSF (filgrastim or pegfilgrastim) was administered at physician discretion to prevent dose reductions or delays. In this real-world cohort, secondary G-CSF prophylaxis during q3-weekly AC chemotherapy was not associated with significant differences in all-cause mortality between groups. No secondary hematological malignancies were observed. These results support the liberaluse of secondary G-CSF in curative-intent regimens to prevent delays or reductions in dose intensity."

Clinical • Breast Cancer • Oncology • Solid Tumor

Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy (clinicaltrials.gov) - P3 | N=250 | Active, not recruiting | Sponsor: Kexing Biopharm Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Chemotherapy-Induced Neutropenia • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

Real-world outcomes of anthracycline and taxane-based perioperative breast cancer therapy using the Japanese electronic medical record database. (PubMed, Jpn J Clin Oncol) - "RDI was high in all groups. Clinicians should be cautious when administering AC q3w therapy owing to the high likelihood of patients developing Grade 4 neutropenia. For TC, a slightly lower pegfilgrastim administration rate and >20% Grade 4 neutropenia suggest the need for appropriate pegfilgrastim use."

Journal • Real-world evidence • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor

BREASTIMMU02: Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2+ Breast Cancer Breast Cancer (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Centre Leon Berard | Trial completion date: Sep 2025 ➔ Sep 2027 | Trial primary completion date: Jan 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

The safety and effectiveness of pegfilgrastim to reduce cancer chemotherapy-induced febrile neutropenia in real-world practice in Japan: a post-marketing surveillance study. (PubMed, Support Care Cancer) - "This survey confirmed that both primary and secondary prophylaxis using pegfilgrastim reduced FN in the real-world setting. No new safety concerns were identified. This survey was retrospectively registered on 26 April 2024 in the University Hospital Medical Information Network Clinical Trial Registry (UMIN000054267)."

Journal • P4 data • Real-world evidence • Back Pain • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Musculoskeletal Pain • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Pain • Solid Tumor

BREASTIMMU02: Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2+ Breast Cancer Breast Cancer (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Centre Leon Berard | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Successful Re-administration of Granulocyte Colony-Stimulating Factor Without Recurrence of Associated Vasculitis: A Case Report. (PubMed, Cureus) - "This case suggests that G-CSF re-administration may be cautiously considered on an individual basis, particularly when vasculitis is well controlled with corticosteroids and a sufficient interval has elapsed. These findings may help guide individualized management in similar clinical situations."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Vasculitis

Uptake of oncology-related biosimilars: a global analysis of usage data. (PubMed, J Natl Cancer Inst) - "Oncology-related biosimilar uptake in the USA was below-average among included countries. Increasing biosimilar uptake may reduce spending, and savings can be reinvested into cancer care. Future research on time trends can help assess barriers and enablers of biosimilar uptake across countries."

Journal • Oncology

Biologic Drug Prices in Medicare Part B After Entry of Biosimilars to the Market. (PubMed, JAMA Netw Open) - "This cohort study used bayesian structural time series models to analyze Medicare Part B Drug average sales price (ASP) data from quarter 1 of 2005 to quarter 1 of 2025, including 7 biologics with biosimilars available for at least 3 years (bevacizumab, epoetin, filgrastim, infliximab, pegfilgrastim, rituximab, and trastuzumab)...In this cohort study, counterfactual analysis found that price reductions from biosimilar entry were more substantial than suggested by simpler pre-post comparisons. However, these savings remained less than those achieved by small-molecule generics, highlighting the need for policy reforms to enhance market competition and realize greater savings."

Journal • Medicare • Reimbursement • US reimbursement

Safety and Efficacy of G-CSF with Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia: A Subgroup Analysis of the Phase II Trial of Venetoclax in Combination with Cladribine, Idarubicin, and Cytarabine (ASH 2024) - P2 | "The trial allowed treating physicians to use filgrastim 300–480 µg daily for prolonged neutropenia or neutropenic fever; a trial amendment integrated pegfilgrastim at a dose of 6 mg SQ once between D5–9 of each cycle...Sixteen (18%) patients had FLT3-ITD — 8 (9%) received gilteritinib and 1 (1%) received midostaurin...FLT3-ITD AML was associated with delayed count recovery, likely due to concurrent TKI use. G-CSF use had no impact on the incidence of AML relapse."

Clinical • Combination therapy • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • ASXL1 • BCOR • BCR • FLT3 • KRAS • RUNX1 • SF3B1 • SRSF2 • STAG2 • U2AF1 • ZRSR2

A Single Center Experience with Using Dose-Adjusted Repoch in Elderly Patients with Large B-Cell Lymphoma (ASH 2023) - "In the CALGB 50303 trial, REPOCH (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) was associated with similar efficacy but increased toxicity compared to RCHOP, however pts with higher risk disease by International Prognostic Index (IPI) had longer progression-free survival (PFS) with REPOCH therapy in the subgroup analysis ( J Clin Oncol, 2019)...Fifty-eight percent of pts in the entire cohort received intrathecal CNS prophylaxis and all pts received pegfilgrastim support... Pts with LBCL 70+ years tolerated dose-adjusted REPOCH 0. 4 mg/d similarly to the entire cohort of all ages indicating that empiric dose reduction for age alone isn't necessary. CR rates were similar (63%) with pts 70+ years compared to pts in the entire cohort of all ages."

Clinical • B Cell Lymphoma • CNS Disorders • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

The Combination of Pegfilgrastim and Filgrastim Improves the Outcomes of Mobilization and Engraftment after Transplantation of Autologous Hematopoietic Stem Cells for the Treatment of Lymphoma (ASH 2023) - "In conclusion, relative to conventional filgrastim mobilization, the conjunctive use of pegfilgrastim and filgrastim demonstrates superior efficacy, non-inferior safety during ASCT. The schedule enhanced the the outcomes of mobilization in the patients of less hematopoietic area. KEY WORDS: Pegylated recombinant human granulocyte-stimulating factor (pegfilgrastim, PEG-rhG-CSF), recombinant human granulocyte-colony stimulating factor (filgrastim, rhG-CSF), lymphoma, hematopoietic stem cell transplantation (HSCT) autologous hematopoietic stem cell mobilization."

Bone Marrow Transplantation • Febrile Neutropenia • Hematological Malignancies • Lymphoma • Oncology • Transplantation • CD34

Final Results of a Phase I/II Trial of Carfilzomib + R-CHOP for Frontline Treatment of Patients with Non-Germinal Center Diffuse Large B-Cell Lymphoma (DLBCL) (ASH 2023) - "All Pts received pegfilgrastim and zoster prophylaxis. KR-CHOP can be delivered safely, without excess cardiac toxicity or peripheral neuropathy. The superior PFS and OS rates for Pts with non-GC DLBCL vs. controls receiving R-CHOP are encouraging but should be interpreted with caution due to inherent selection bias in clinical trial populations."

Clinical • P1/2 data • Anemia • B Cell Lymphoma • Cardiovascular • Congestive Heart Failure • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Heart Failure • Hematological Malignancies • Herpes Zoster • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Non-Hodgkin’s Lymphoma • Plasmacytoma • Pulmonary Disease • Thrombocytopenia

Impact of Daratumumab-Containing Induction Therapy on Stem Cell Mobilization in Multiple Myeloma: A Retrospective, Single-Center Analysis (ASH 2024) - "In the multivariate logistic regression analysis, independent predictors of plerixafor use included lenalidomide exposure (exp(β) 1.90, 95% CI 1.01-3.55, p = 0.04) and pegfilgrastim as the mobilization strategy compared to filgrastim (pegfilgrastim, exp(β) 4.11, 95% CI 2.37-7.07, p < 0.001). Despite the limitations in our study, we conclude that in our cohort, daratumumab-containing induction therapy did not significantly impact stem cell mobilization in patients with MM. However, these findings require further validation by prospective, randomized larger studies."

Retrospective data • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • CD34