Pegfilgrastim 6mg/0.6ml solution for injection pre-filled disposable devices

A World Health Organisation panel previously recommended the use of hematopoietic cytokines to manage H-ARS within 24 h of exposure to ⩾2 Gy radiation dose, a recommendation that has been endorsed by hematologists and oncologists with expertise in radiation management. Nevertheless, no state-of-the-art consensus has been reached regarding categorical selection of cytokines for emergency scenarios involving accidental exposures where implementation of planned and/or extended countermeasures is certain or likely (International Nuclear and Radiological Event Scale levels 5, 6 and 7) or an exposure from a detonated nuclear weapon. A systematic review of the published literature was conducted (422 citations identified, 391 of which were screened) in non-human primates 9 meeting inclusion criteria), and in reviews of human cases treated with cytokines in a search of the MEDLINE database (1970-present), websites/official publications of major national and international organisations and radiation societies, cytokine reviews and full prescribing information. In contrast to filgrastim, pegfilgrastim and romiplostim, sargramostim augments the differentiation and proliferation of multiple lymphohematopoietic lineages. NHP survival benefits without the support of blood products was reported with sargramostim or pegfilgrastim plus romiplostim. Four cytokine reviews met criteria for summarising published reports of 63 human cases that included at least one case meeting inclusion criteria. Cytokine efficacy was documented when administered at up to 96 h after NHP exposure for sargramostim and at 24 h but not 48 h after exposure for filgrastim, pegfilgrstim or pegfilgrastim plus romiplostim. Ease of use favoured pegfilgrastim (administered weekly x2) and romiplostim (administered once), compared to filgrastim and sargramostim (administered daily x5 and x14, respectively). Formal assessment of the published evidence is urgently needed to provide categorical guidance regarding cytokine use for patient management, and to public health officials involved in establishing a national or shared regional radiation stockpile for immediate use in a mass casualty radiological/nuclear (R/N) emergency.

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Abstract Purpose: Chemotherapy-induced neutropenia (CIN) is a common complication that increases the risk of infection, hospitalization, and treatment delays. While granulocyte colony-stimulating factors (G-CSFs) like filgrastim and pegfilgrastim are used to reduce these risks, limitations in dosing schedules and variability remain. Efbemalenograstim alfa (F-627), a novel long-acting recombinant G-CSF, has emerged as a potential alternative. This systematic review and meta-analysis aimed to evaluate its comparative safety and efficacy against standard G-CSFs in patients undergoing chemotherapy for non-myeloid malignancies. Methods: A comprehensive literature search was conducted across six databases for randomised controlled trials (RCTs) comparing F-627 to standard G-CSFs. Data from three active-controlled trials were pooled using Review Manager (RevMan) 5.4.1, with results expressed as risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. Heterogeneity was assessed using the I² statistic. Narrative synthesis was performed for the data in the placebo-controlled trial and outcomes with insufficient data for meta-analysis. Risk of bias and evidence quality were evaluated using the Cochrane RoB 2.0 tool and GRADE guidelines, respectively. Results: Four RCTs comprising 973 patients were included, with 533 receiving F-627. F-627 showed comparable efficacy to standard G-CSFs in reducing duration of Grade 4 neutropenia in cycle 1 (MD = 0.04 days; 95% CI: − 0.04 to 0.13; I² = 0%). Incidence of severe neutropenia and febrile neutropenia were also similar (RR = 1.02; 95% CI: 0.97–1.07 and RR = 1.33; 95% CI: 0.41–4.30, respectively). However, a placebo-controlled trial showed a significant reduction in neutropenia and febrile neutropenia incidence with F-627. Secondary outcomes and adverse event profiles were broadly comparable across treatment arms. Conclusion Efbemalenograstim alfa offers a comparable safety and efficacy profile to standard G-CSFs for the prevention of CIN, supporting its role as a viable therapeutic option in non-myeloid cancers.

Abstract licence: CC BY