biostudies-literatureMora JNCI NIH HHSe1627https://www.ebi.ac.uk/biostudies/studies/S-EPMC9875606biostudies-literatureUnknown6(1)<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 tachycardiCancer reports (Hoboken, N.J.)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.PMC9875606P30 CA008748Bear MKChan GCNysom KTornoe KKushner BHMora JMorgenstern DAfalseOutpatient 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.<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 tachycardi2023-01-01T00:00:00Z2023 Jan2026-05-29T05:31:58.178Z2025-04-05T20:20:31.837ZS-EPMC98756063557986210.1002/cnr2.1627