{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Mora J"],"funding":["NCI NIH HHS"],"pagination":["e1627"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9875606"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["6(1)"],"pubmed_abstract":["<h4>Background</h4>Naxitamab is a humanized GD2-binding monoclonal antibody that received accelerated approval from the U.S. Food and Drug Administration for refractory or relapsed high-risk neuroblastoma limited to bone or bone marrow. Trial 201 (NCT03363373) is an ongoing global clinical trial to evaluate the efficacy and safety of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in this population.<h4>Aims</h4>Here, we review the safety profile and adverse event (AE) management associated with naxitamab administration in a pediatric population, based on Trial 201 protocol guidelines and clinical trial experience.<h4>Methods and results</h4>At least 50% of patients experienced pain, hypotension, bronchospasm, cough, vomiting, diarrhea, nausea, and tachycardi"],"journal":["Cancer reports (Hoboken, N.J.)"],"pubmed_title":["Outpatient administration of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in patients with refractory and/or relapsed high-risk neuroblastoma: Management of adverse events."],"pmcid":["PMC9875606"],"funding_grant_id":["P30 CA008748"],"pubmed_authors":["Bear MK","Chan GC","Nysom K","Tornoe K","Kushner BH","Mora J","Morgenstern DA"],"additional_accession":[]},"is_claimable":false,"name":"Outpatient administration of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in patients with refractory and/or relapsed high-risk neuroblastoma: Management of adverse events.","description":"<h4>Background</h4>Naxitamab is a humanized GD2-binding monoclonal antibody that received accelerated approval from the U.S. Food and Drug Administration for refractory or relapsed high-risk neuroblastoma limited to bone or bone marrow. Trial 201 (NCT03363373) is an ongoing global clinical trial to evaluate the efficacy and safety of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in this population.<h4>Aims</h4>Here, we review the safety profile and adverse event (AE) management associated with naxitamab administration in a pediatric population, based on Trial 201 protocol guidelines and clinical trial experience.<h4>Methods and results</h4>At least 50% of patients experienced pain, hypotension, bronchospasm, cough, vomiting, diarrhea, nausea, and tachycardi","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Jan","modification":"2026-05-29T05:31:58.178Z","creation":"2025-04-05T20:20:31.837Z"},"accession":"S-EPMC9875606","cross_references":{"pubmed":["35579862"],"doi":["10.1002/cnr2.1627"]}}