Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim
Sign Up to like & getrecommendations! Published in 2020 at "Cancer Medicine"
DOI: 10.1002/cam4.3261
Abstract: Our aim was to compare the efficacy and safety of two recently developed biosimilars of pegfilgrastim, a pegylated form of the recombinant human granulocyte‐colony stimulating factor (G‐CSF) analog filgrastim with those of the reference pegfilgrastim.… read more here.
Keywords: efficacy safety; safety; reference; pegfilgrastim ... See more keywords
NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim
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DOI: 10.1007/s00520-017-3959-2
Abstract: PurposeMild-to-moderate bone pain is a commonly reported adverse event (AE) associated with pegfilgrastim. We evaluated the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on pegfilgrastim-associated bone pain.MethodsIn this open-label study (NCT01712009), women… read more here.
Keywords: treatment; naproxen loratadine; bone; pegfilgrastim ... See more keywords
Febrile neutropenia (FN) and pegfilgrastim prophylaxis in breast cancer and non-Hodgkin’s lymphoma patients receiving high (> 20%) FN-risk chemotherapy: results from a prospective observational study
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DOI: 10.1007/s00520-018-4473-x
Abstract: PurposeProphylaxis for febrile neutropenia (FN) is recommended for the duration of myelosuppressive chemotherapy in high-risk patients; yet, granulocyte-colony-stimulating factor (G-CSF) discontinuation occurs frequently in clinical practice. The objective of this study was to investigate the… read more here.
Keywords: risk; high risk; study; discontinuation ... See more keywords
Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies
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DOI: 10.1007/s12325-021-02024-x
Abstract: Biologic therapeutics can trigger immune responses in patients. As part of the totality of evidence that is required for regulatory approval of biosimilars, immunogenicity similarity must be assessed in the clinical programs. Pegfilgrastim-cbqv (UDENYCA®) is… read more here.
Keywords: immunogenicity pegfilgrastim; immunogenicity; pegfilgrastim; pegfilgrastim cbqv ... See more keywords
Single-Dose Pharmacokinetics, Pharmacodynamics and Immunogenicity, and Multiple-Dose Immunogenicity of INTP5 (Pegfilgrastim Biosimilar) Versus Reference Pegfilgrastim in Healthy Subjects
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DOI: 10.1007/s40261-020-00987-3
Abstract: Background and Objective INTP5 has been developed as a pegfilgrastim biosimilar. Single-dose, crossover study compared the pharmacokinetics and pharmacodynamics (PK/PD) of INTP5 (pegfilgrastim biosimilar) with reference pegfilgrastim (Neulasta ® , pegfilgrastim-ref) and a multiple-dose, parallel-group study compared the… read more here.
Keywords: immunogenicity; intp5; pegfilgrastim ref; pegfilgrastim ... See more keywords
The ELISA Detectability and Potency of Pegfilgrastim Decrease in Physiological Conditions: Key Roles for Aggregation and Individual Variability
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DOI: 10.1038/s41598-020-59346-z
Abstract: PEGylated recombinant human granulocyte colony stimulating factor (pegfilgrastim) is used clinically to accelerate immune reconstitution following chemotherapy and is being pursued for biosimilar development. One challenge to overcome in pegfilgrastim biosimilar development is establishing pharmacokinetic… read more here.
Keywords: individual variability; variability elisa; variability; pegfilgrastim ... See more keywords
A review of the totality of evidence supporting the development and approval of a pegfilgrastim biosimilar (LA-EP2006)
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DOI: 10.1080/03007995.2022.2061707
Abstract: Abstract Objective The totality-of-evidence approach requires that similarity between a proposed biosimilar and a reference biologic is demonstrated across a range of analytical, preclinical, and clinical parameters to establish biosimilarity. We describe the totality of… read more here.
Keywords: reference biologic; reference; pegfilgrastim; totality evidence ... See more keywords
Impact of relative dose intensity of trabectedin with pegfilgrastim support: a single-centre retrospective study.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of chemotherapy"
DOI: 10.1080/1120009x.2022.2164116
Abstract: Relative dose intensity (RDI) has been associated with improved survival in patients with advanced solid tumours. However, there is no evidence regarding RDI in patients under long-term treatment with trabectedin for adult advanced soft tissue… read more here.
Keywords: dose intensity; relative dose; trabectedin; pegfilgrastim ... See more keywords
Early administration of pegfilgrastim for esophageal cancer treated with docetaxel, cisplatin, and fluorouracil: A phase II study
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DOI: 10.1111/cas.14218
Abstract: Preoperative or induction chemotherapy with docetaxel, cisplatin, plus 5‐fluorouracil (DCF) is a promising regimen for advanced esophageal cancer. However, the DCF regimen is associated with a high risk of severe neutropenia or febrile neutropenia (FN).… read more here.
Keywords: esophageal cancer; pegfilgrastim; cancer; phase study ... See more keywords
Evaluation of a novel medical device for pegfilgrastim administration
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DOI: 10.1111/cas.15335
Abstract: Pegfilgrastim, a pegylated form of granulocyte colony‐stimulating factor, has reduced the risk of developing febrile neutropenia, which is associated with an increase in severe infection and prolonged hospitalization. However, pegfilgrastim administration requires that patients visit… read more here.
Keywords: administration; pegfilgrastim administration; chemotherapy; study ... See more keywords
Abstract P3-14-10: Proposed biosimilar pegfilgrastim LA-EP2006 shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects
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DOI: 10.1158/1538-7445.sabcs17-p3-14-10
Abstract: Background: Granulocyte colony-stimulating factors such as filgrastim and its long-acting version pegfilgrastim are widely used to prevent neutropenia in patients receiving chemotherapy. LA-EP2006 is a proposed biosimilar pegfilgrastim that has been compared with reference pegfilgrastim… read more here.
Keywords: similarity; reference pegfilgrastim; ep2006 reference; reference ... See more keywords