Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar

Hoy, Sheridan M.

doi:10.1007/s40259-019-00334-9

Cited by 4 publications

(1 citation statement)

References 3 publications

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“…10,12,[40][41][42][43][44] Pegfilgrastim-jmdb has been shown to have high analytical and functional similarity to pegfilgrastim, with similar structure, molecular mass, physicochemical characteristics, and G-CSF receptor binding affinity. 45,46 A phase I randomized equivalence trial concluded that pegfilgrastim-jmdb demonstrated similar pharmacokinetics, pharmacodynamics, and safety to pegfilgrastim in healthy volunteers. 40 In a multicenter randomized phase III efficacy and safety trial, patients with breast cancer receiving myelosuppressive chemotherapy with pegfilgrastim-jmdb support showed no difference in duration of severe neutropenia, time to absolute neutrophil count (ANC) nadir, duration of postnadir recovery, or treatment-related adverse events compared with patients receiving reference pegfilgrastim.…”

Section: Filgrastim-aafimentioning

confidence: 99%

NCCN Guidelines Insights: Hematopoietic Growth Factors, Version 1.2020

Becker

Griffiths²,

Alwan

et al. 2020

Journal of the National Comprehensive Cancer Network

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Management of febrile neutropenia (FN) is an integral part of supportive care for patients undergoing cancer treatment. The NCCN Guidelines for Hematopoietic Growth Factors provide suggestions for appropriate evaluation, risk determination, prophylaxis, and management of FN. These NCCN Guidelines are intended to guide clinicians in the appropriate use of growth factors for select patients undergoing treatment of nonmyeloid malignancies. These NCCN Guidelines Insights highlight important updates to the NCCN Guidelines regarding the incorporation of newly FDA-approved granulocyte-colony stimulating factor biosimilars for the prevention and treatment of FN.

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