Biosimilar Filgrastim (Tevagrastim, XMO2) for Allogeneic Hematopoietic Stem Cell Mobilization and Transplantation in Patients with Acute Myelogenous Leukemia/Myelodysplastic Syndromes

Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation
Ivetta DanyleskoA Nagler

Abstract

Human recombinant granulocyte colony-stimulating factor (G-CSF), filgrastim (Neupogen; Amgen, Thousand Oaks, CA, USA), has been widely used for the mobilization of CD34(+) hematopoietic stem cells (HSC) from healthy donors. The experience with biosimilar G-CSF agents in this area is limited. We performed a prospective study assessing Tevagrastim (biosimilar filgrastim, XMO2; Teva, Israel) for mobilization of CD34(+) peripheral blood HSC in HLA-matched healthy sibling donors for transplantation in 24 patients with acute myelogenous leukemia (AML) and high-risk myelodysplastic syndromes (MDS) (NCT01542944). Results were compared to a historical control group of sibling donors who received filgrastim for stem cell mobilization for allogeneic stem cell transplantations in patients with AML and MDS. The healthy donors received Tevagrastim or filgrastim in a dose of 10 μg/kg body weight (BW) subcutaneously for 4 days. The target yields of CD34(+) cells was 5 × 10(6) CD34(+) cells/kg BW of the recipient. A median 10.2 × 10(6) (range, 2.52 to 35.4) and 9.35 × 10(6) (range, 3.7 to 30.6) CD34(+) cells per kg BW were collected in the Tevagrastim and filgrastim groups, respectively. All patients promptly engrafted with a median day of abso...Continue Reading

Citations

Aug 24, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Pere GasconMatti Aapro
Mar 30, 2016·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Hannah A Blair, Lesley J Scott
Oct 5, 2018·Bone Marrow Transplantation·Simon PahnkeUNKNOWN Working Group Medical of the World Marrow Donor Association
May 16, 2021·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·José Cleberson Santos SoaresJuliana Lúcia de Albuquerque Vasconcelos

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