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

Atypical Bullous Sweet Syndrome. (PubMed, R I Med J (2013)) - "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."

Journal • Acute Myelogenous Leukemia • Dermatology • Hematological Malignancies • Leukemia • Oncology

Prophylactic use of G-CSFs to reduce neutropenia rates in patients treated with antibody-drug conjugates: A literature review. (PubMed, Eur J Cancer) - "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."

Journal • Review • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Neutropenia

Anaphylaxis to both pegfilgrastim and sargramostim in a patient with diffuse large B-cell lymphoma. (PubMed, BMJ Case Rep) - "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...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..."

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

Neutropenia in Patients With Castration-Resistant Prostate Cancer Treated Using Cabazitaxel and Prophylactic Administration of Pegfilgrastim. (PubMed, Adv Urol) - "Cabazitaxel was administered every 3-4 weeks at doses determined by the treating physicians, generally 20-25 mg/m2, with daily oral prednisolone...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."

Journal • Castration-Resistant Prostate Cancer • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

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

Pegfilgrastim-Associated Syndrome of Inappropriate Antidiuretic Hormone Secretion in Burkitt Lymphoma: A Case Report (SOHO 2026) - "Case Presentation: A 73-year-old woman with newly diagnosed sporadic Burkitt lymphoma (BL; stage 3A) and normal baseline sodium (139 mmol/L) was started on dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab (EPOCH-R). Pegfilgrastim-induced SIADH is rare but potentially life-threatening. Clinicians should monitor electrolytes following pegfilgrastim administration, particularly in elderly patients receiving intensive chemotherapy, and consider pegfilgrastim as a potential etiology when evaluating new-onset hyponatremia in this setting."

Case report • Clinical • Burkitt Lymphoma • Chemotherapy-Induced Neutropenia • Hematological Malignancies • Lymphoma • Oncology

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

Phase I, two-part, multicenter first-in-human (FIH) study of TORL-1-23: A novel claudin 6 (CLDN6) targeting antibody drug conjugate (ADC) in patient with advanced solid tumors (ESMO 2024) - P1 | "Part 2 enrolled 20 pts with ovarian (n=11), endometrial (n=4), NSCLC (n=4), and testicular (n=1) cancers at 2.4 mg/kg (n=12) and 3.0 mg/kg (n=8) with pegfilgrastim. TORL-1-23 is well tolerated with promising preliminary antitumor activity in heavily-pretreated pts with CLDN6-expressing ovarian, endometrial, and testicular cancers. Dose expansion is ongoing at doses of 2.4mg/kg and 3.0mg/kg in CLDN6+ NSCLC and ovarian cancer, and CLDN6-low expressing tumors."

Clinical • Metastases • P1 data • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Testicular Cancer • CLDN6

Comparative Outcomes of Pegfilgrastim vs Filgrastim in Older Patients With Diffuse Large B-Cell Lymphoma Receiving R-CHOP: A Real-World Propensity-Matched Study (SOHO 2026) - "Background: Granulocyte colony-stimulating factors are routinely used for primary prophylaxis against chemotherapy-related neutropenic complications in patients receiving R-CHOP for DLBCL. In this large real-world propensitymatched study of older patients with DLBCL receiving R-CHOP, pegfilgrastim prophylaxis was associated with lower risks of infectious complications and all-cause mortality compared with filgrastim. These findings suggest that pegfilgrastim may represent an effective prophylactic strategy in high-risk older adults receiving curative-intent chemoimmunotherapy. Further prospective studies are warranted to confirm these findings."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Efficacy and safety of iberdomide, daratumumab, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma. (ASCO 2026) - P1/2 | "Most common toxicities at RP2D were lymphopenia, neutropenia (leading 27% of pts to require pegfilgrastim support), rash, peripheral neuropathy, diarrhea, & infections. Iber-DVd is an active and safe regimen for both TE and TIE pts with NDMM, leading to high response rates which improved over time, with nearly one-half of the pts achieving MRD negative state."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Targeted Protein Degradation • CRBN

Long-Term Follow-up and updated analysis from S0221, Comparing Alternative Dose-Schedules of Adjuvant Anthracycline/Taxane Therapy in High-Risk Early Breast Cancer. (SABCS 2024) - " S0221 investigated weekly (arms 2 and 4) doxorubicin (A)/cyclophosphamide (C) + granulocyte colony stimulating factor (GCSF; filgrastim or pegfilgrastim) versus (vs.) every 2 weeks (Q2W) (arms 1 and 3) schedule AC, followed by paclitaxel (P) given Q2W or weekly for 12 weeks as post-operative adjuvant therapy in node-positive or high-risk node-negative breast cancer. As there were no significant outcome differences in DFS or OS between the studied schedules with extended follow-up in the original cohort or in the additional 578 patients treated on the revised protocol, either paclitaxel schedule may be recommended, with selection based on toxicity, cost, or patient preference rather than efficacy. [AA1]Character limit allowed 3400"

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy of prophylactic pegfilgrastim compared with therapeutic filgrastim for preventing febrile neutropenia during chemotherapy for musculoskeletal tumors: A single-center retrospective study. (PubMed, J Orthop Sci) - "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."

Journal • Retrospective data • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Musculoskeletal Diseases • Neutropenia • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Claudin- 6 (CLDN6) is a therapeutic target in ovarian cancer (OC): Emerging results from the CATALINA 1 (CAT1) study (ESMO 2025) - P1 | "For all OC: median prior lines 3 (1-9); 73% received prior bevacizumab, 67% prior PARP inhibitors, and 11% prior mirvetuximab. OC pts received doses 3.0 mg/kg (11) with doses ≥3.0 mg/kg given with prophylactic pegfilgrastim (peg)...TORL-1-23 was generally well tolerated with an acceptable safety profile. These proof-of-concept data support further evaluation of TORL-1-23 in larger, registration studies that are now ongoing."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN6

Plinabulin to shorten neutropenia and improve quality of life peri-autologous hematopoietic cell transplant. (ASCO 2023) - P2 | "To decrease the period of myelosuppression and obligate neutropenia after high dose melphalan with autologous hematopoietic stem cell transplantation (AHCT) for patients with multiple myeloma, we studied the addition of plinabulin to standard growth factors. To achieve the primary objective of reducing the duration of absolute neutropenia post AHCT, 40mg of intravenous plinabulin was given 1-3 hours after stem cell infusion (Day 0) with pegfilgrastim on Day +1 in this pilot trial (NCT05130827)... Plinabulin appears well tolerated without additional major toxicities post AHCT and provided a high WBC on Day +2 and decreased rate of neutropenic fever. Plinabulin PK, quality of life data, and PROs will be presented. Adjusting the schedule of plinabulin to later post AHCT pre engraftment may further shorten the duration of neutropenia using this novel mechanism of action."

HEOR • Bone Marrow Transplantation • Cardiovascular • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Hypertension • Immune Modulation • Multiple Myeloma • Neutropenia • Oncology • Solid Tumor • Transplantation • CD34

Neoadjuvant Durvalumab ± Tremelimumab in Combination With Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Muscle-Invasive Bladder Carcinoma: Results of the Phase I/II NEMIO Study. (PubMed, J Clin Oncol) - P1/2 | "Neoadjuvant ddMVAC plus durvalumab demonstrated encouraging pCR rates, favorable early survival outcomes, and manageable safety profile. Adding tremelimumab provides similar pCR but worse toxicity. These results support further study of ddMVAC plus durvalumab as a neoadjuvant chemoimmunotherapy strategy for localized MIBC, to be evaluated in comparative trials within an evolving perioperative treatment landscape."

Journal • P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

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 2026 ➔ Jul 2027

Trial 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

Accelerated Methotrexate, Vinblastine, Doxorubicin, and Cisplatin for Muscle-Invasive Bladder Cancer: Real-World Feasibility and Safety in a Resource-Constrained Setting. (PubMed, JCO Glob Oncol) - "Single-day AMVAC is a feasible and tolerable NAC regimen in a resource-constrained setting, with encouraging PCR and manageable toxicity."

Journal • Real-world evidence • Bladder Cancer • Fatigue • Genito-urinary Cancer • Hematological Disorders • Mucositis • Oncology • Solid Tumor

Gemcitabine/paclitaxel/adriamycin (GTA) as a nephron-sparing regimen in urothelial carcinoma: The MD Anderson Cancer Center (MDACC) experience. (ASCO 2024) - "Background: GTA (Gemcitabine 900 mg/m2 IV; Paclitaxel 135 mg/m2 IV and Adriamycin 30 mg/m2 IV, with pegfilgrastim 6mg SQ on a 14-day cycle) was initially reported from a prospective phase II study of 39 patients (pts) by Siefker-Radtke et al. GTA shows modest efficacy as a 1L regimen in LA/mUC. The facilitation of cisplatin-based regimens after GTA in a subset of pts might be explained by restoring patency in partially obstructed collecting systems. This 'GTA bridging' strategy may be beneficial for pts for whom nephrostomy or ureteral stenting proves impractical or insufficient to address renal insufficiency."

Nephrology • Oncology • Renal Disease • Solid Tumor • Urology • Urothelial Cancer

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

Enrollment open • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD4

Risk of febrile neutropenia in breast cancer chemotherapy despite the prophylactic use of pegfilgrastim: a retrospective analysis. (PubMed, Breast Cancer) - "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."

Journal • Retrospective data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Efficacy of Early Pegfilgrastim Administration during Preoperative Docetaxel, Cisplatin, and 5-Fluorouracil Therapy in Esophageal Cancer. (PubMed, JMA J) - "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."

Journal • Anorexia • Cardiovascular • Esophageal Cancer • Febrile Neutropenia • Heart Failure • Leukopenia • Neutropenia

Carboplatin Monotherapy Induced Complete Response in Elderly Metastatic Seminoma and CKD: A Case Report. (PubMed, IJU Case Rep) - "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."

Journal • Monotherapy • Chronic Kidney Disease • Genito-urinary Cancer • Geriatric Disorders • Germ Cell Tumors • Hematological Disorders • Nephrology • Oncology • Renal Disease • Solid Tumor • Testicular Cancer • Testicular Seminoma

Comparative efficacy and safety of four long-acting granulocyte colony-stimulating factors for primary prophylaxis in patients with breast cancer: a prospective observational cohort study in China. (PubMed, EClinicalMedicine) - "Patients received subcutaneous pegfilgrastim, mecapegfilgrastim, telpegfilgrastim, or efbemalenograstim alfa once per cycle per clinical practice...Larger prospective studies are needed to confirm these exploratory findings. None."

Journal • Observational data • Breast Cancer • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Leukopenia • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Solid Tumor

A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers (clinicaltrials.gov) - P1 | N=202 | Recruiting | Sponsor: Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

New P1 trial

Improving engraftment in autologous hematopoietic stem cell transplantation: comparing pegfilgrastim with filgrastim in an outpatient setting. (PubMed, Hematol Transfus Cell Ther) - "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."

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