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

Case Report: Solitary adrenal metastasis from esophageal adenocarcinoma. (PubMed, Front Med (Lausanne)) - "The patient reported fatigue, bone pain managed with Neulasta, nausea controlled with antiemetics, and neuropathy in his feet. The patient then began a new chemotherapy regimen with Taxol/Ramucirumab with dose modifications in response to side effects...This case highlights the need for careful selection to identify patients who may benefit from aggressive surgical treatment. Ongoing research and clinical trials are needed to better define treatment protocols and improve outcomes for this challenging patient group."

Journal • Constipation • Esophageal Adenocarcinoma • Esophageal Cancer • Fatigue • Gastric Cancer • Gastroenterology • Gastrointestinal Disorder • Musculoskeletal Pain • Oncology • Pain • Palliative care • Solid Tumor

Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain: A Prospective, Randomized Phase 3 Trial (ESMO 2025) - No abstract available

Clinical • P3 data • Breast Cancer • Oncology • Solid Tumor

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jul 2025 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Oct 2024

Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

The proposal to expand reimbursement for Amgen Korea's Blincyto (blinatumomab) and the neutropenia treatment component pegfilgrastim, such as Neulasta by Kyowa Kirin Korea, has been approved by the CDRC. (Korea Biomedical Review) - "Blincyto establishes its reimbursement criteria for indications in the consolidation therapy of adult and pediatric patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (ALL). At the same time, pegfilgrastim-containing formulations received coverage for treating febrile neutropenia and reducing the duration of neutropenia in patients undergoing cytotoxic chemotherapy for malignant tumors."

Reimbursement • B Acute Lymphoblastic Leukemia • Chemotherapy-Induced Neutropenia

Efficacy and safety of etoposide + cytarabine + pegfilgrastim mobilization regimen versus G-CSF mobilization regimen alone for hematopoietic stem cell mobilization in patients with multiple myeloma and lymphoma. (PubMed, Cytotherapy) - "The EAP regimen demonstrated significantly enhanced mobilization efficiency compared to the G-CSF monotherapy while maintaining an acceptable toxicity profile. These findings suggest that the EAP regimen may represent a superior alternative for mobilizing hematopoietic stem cells in patients with multiple myeloma or lymphoma."

Journal • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • Transplantation • CD34

Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P2 | N=31 | Not yet recruiting | Sponsor: Medical College of Wisconsin | Initiation date: Jun 2025 ➔ Oct 2025

Trial initiation date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Analysis of remobilization efficiency of etoposide combined with cytarabine and pegfilgrastim, with or without plerixafor, for multiple myeloma recurrence following autologous hematopoietic stem cell transplantation. (PubMed, Clin Exp Med) - No abstract available

Journal • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies (clinicaltrials.gov) - P1/2 | N=67 | Recruiting | Sponsor: University of California, Irvine

New P1/2 trial • Breast Cancer • Cervical Cancer • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer • KRAS

Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=34 | Not yet recruiting | Sponsor: Abramson Cancer Center at Penn Medicine

New P2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A new STAT3-based potency assay for human G-CSF analog therapeutics. (PubMed, J Pharm Biomed Anal) - "This new potency reporter assay was linear and accurate over the range of 25-200 % of the reference material potency, and the assay demonstrated acceptable specificity, precision, and robustness. This reporter cell assay platform may also be applied to develop assays for potency determinations of other therapeutics in the rhG-CSF class."

Journal • Hematological Disorders • Neutropenia • Oncology • CSF3R • STAT3

A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: PharmaEssentia | Trial completion date: Jun 2025 ➔ Feb 2025 | Enrolling by invitation ➔ Completed

Trial completion • Trial completion date

Filgrastim 300mcg on Days 8 and 12 for the AC-T Dose-Dense Regimen (MASCC-ISOO 2025) - "Introduction In the AC-T dose-dense regimen (every 2 weeks), hematopoietic growth factors such as filgrastim (G-CSF) 5 mcg/kg SC (rounded to 300 mcg or 480 mcg) on days 3–10 or pegfilgrastim 6 mg SC on day 2 or 3 are often required...Results 790 breast cancer patients received the AC-T regimen:AC cycles: 3160 (doxorubicin + cyclophosphamide, every 2 weeks).Paclitaxel cycles: 3160 (every 2 weeks).Filgrastim was administered at 300 mcg on days 8 and 12 during AC and omitted during paclitaxel.Median age: 45 years (28–60).Median weight: 55 kg (38–96 kg).No chemotherapy discontinuations.Grade 2–4 anemia: 0%.Neutropenia: 0.07% (AC), 1.01% (paclitaxel).Grade 2–4 thrombocytopenia: 0%.Bone pain: 15% after the second dose of filgrastim.No deaths during chemotherapy. Conclusions The results demonstrate that the dose-dense AC-T regimen (administered every 2 weeks) requires only filgrastim support at 300 mcg on days 8 and 12 during AC treatment, with no filgrastim needed during..."

Anemia • Breast Cancer • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor • Thrombocytopenia

EMPEGFILGRASTIM SUPPORT FOR FULL-DOSE THERAPY OF 6-EACODD-14 PROGRAM FOR ADVANCED STAGES HODGKIN'S LYMPHOMA PATIENTS. (EHA 2025) - "Single dose administration of pegfilgrastim has been demonstrated to be not inferior to filgrastim in terms of efficacy and could enable the delivery of the full dose of BEACOPP chemotherapy every 14 days...Chemotherapy of 6 cycles modified EACODD-14 program (etoposide, doxorubicin, cyclophosphamide, vincristine, dacarbazine, dexamethasone) in the "LH-Russia-1" protocol was performed in 43 patients with newly diagnosed high-risk cHL - stages IIB bulky, III/IV... The results of the study show the advantage of using of new prolonged form of G-CSF empegfilgrastim in the EACODD-14 program on the 4th or 5th day of the cycle to support full-dose regimen comparing the using filgrastim on the 9th-13th days of the same cycle. The lower incidence of infectious complications associated with deep neutropenia and the lower frequency of erythrocyte transfusions when using empegfilgrastim also indicate its advantage compared to filgrastim."

Clinical • Metastases • Classical Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukopenia • Lymphoma • Neutropenia • Oncology

PEGFILGRASTIM VS. FILGRASTIM FOR FEBRILE NEUTROPENIA PREVENTION IN THE FIRST CYCLE OF POLATUZUMAB VEDOTIN-R-CHP (POLA-R-CHP): A NATIONWIDE COHORT STUDY IN NEWLY DIAGNOSED DIFFUSE LARGE B-CELL LYMPHOMA (EHA 2025) - "The phase 3 POLARIX trial demonstrated that pola-R-CHP improved progression-free survival compared to R-CHOP. Pegfilgrastim had a lower FN incidence and a shorter hospital stay compared to filgrastim in newly diagnosed DLBCL patients receiving the first cycle of pola-R-CHP."

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

ETOPOSIDE+CYTARABINE+PEGFILGRASTIM VS CYCLOPHOSPHAMIDE+GRANULOCYTE COLONY-STIMULATING FACTOR FOR STEM-CELL MOBILIZATION IN PATIENTS WITH MULTIPLE MYELOMA: A PHASE III TRIAL (EHA 2025) - P3 | "Using a stratified block randomization technique, adults with recently diagnosed MM were randomized in a 2:1 ratio to either the experimental (EAP) or control (CG) groups, based on their previous exposure to lenalidomide (>4 cycles vs. ≤4 cycles). Higher percentages of patients reached optimum and target thresholds after fewer apheresis sessions, indicating that EAP was more effective than CG in generating optimal HSC yields. It had tolerable toxicity and an acceptable safety profile. The low usage of plerixafor highlights EAP's independence and points to it as a potential first-line mobilization regimen for MM patients, especially those who are unable to take plerixafor."

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

P3BEP: Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: University of Sydney | Trial completion date: Jul 2023 ➔ Dec 2029 | Trial primary completion date: Feb 2022 ➔ Dec 2029

Trial completion date • Trial primary completion date • Germ Cell Tumors

ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=38 | Not yet recruiting | Sponsor: Michael Spinner, MD

Circulating tumor DNA • New P2 trial • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

SWOG S1826: Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma (clinicaltrials.gov) - P3 | N=994 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2025 ➔ Mar 2026

Trial completion date • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Association Between Baseline Neutrophil Count and Febrile Neutropenia Following Docetaxel and Ramucirumab With Prophylactic Pegfilgrastim. (PubMed, Thorac Cancer) - "Our data showed the incidence rate of FN receiving DTX + RAM with prophylactic pegfilgrastim was 5.5%. Despite prophylactic pegfilgrastim, BNC was correlated with LNC and might be predictive of FN. We should be careful of BNC even if it meets the criteria for starting DTX + RAM treatment."

Journal • Retrospective data • Cardiovascular • Febrile Neutropenia • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: University of Washington | Initiation date: Jun 2025 ➔ Sep 2025

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=244 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Large vessel vasculitis associated with atezolizumab. (PubMed, BMJ Case Rep) - "Existing literature has documented large vessel vasculitis in association with ipilimumab, pembrolizumab and nivolumab therapy. Although large vessel vasculitis was reported in one patient who had received both atezolizumab and pegfilgrastim, our patient represents the first instance of large vessel vasculitis associated with atezolizumab alone. Discontinuation of atezolizumab and tapered glucocorticoid therapy resulted in clinical and radiographic resolution."

Journal • Gastric Cancer • Hematological Disorders • Immunology • Myositis • Oncology • Rheumatology • Solid Tumor • Vasculitis

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Yeon Hee Park | Initiation date: Jan 2025 ➔ Jun 2025

Trial initiation date • Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

Case of Fatal Oxaliplatin-induced Pulmonary Toxicity (ATS 2025) - "Various chemotherapy agents are known to cause pulmonary toxicity such as bleomycin, busulfan, cyclophosphamide and actinomycin-D...CASE PRESENTATION: A 78-year-old woman with stage 3A serous cystadenoma ovarian cancer had previously undergone a total abdominal hysterectomy with bilateral salpingo-oophorectomy, followed by six cycles of carboplatin and paclitaxel, remaining recurrence-free...FOLFOXIRI/pegfilgrastim (folinic acid, 5-fluorouracil, oxaliplatin, irinotecan) was initiated, but due to oral blisters and ulcers, a 20% dose reduction was implemented in the second cycle...Treatment with intravenous immunoglobulin (IVIG), antibiotics, Rituximab, and ARDS protocol was ineffective, leading to ARDS, renal failure, and multi-organ failure...Few patients showed improvement with oxaliplatin discontinuation, while others responded to glucocorticoids, N-acetylcysteine (NAC), cyclophosphamide, and IVIG...We recommend monitoring patients with underlying pulmonary disease..."

Clinical • Acute Respiratory Distress Syndrome • Colorectal Cancer • Gynecology • Immunology • Interstitial Lung Disease • Oncology • Ovarian Cancer • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • Solid Tumor