Naxitamab is a GD2-directed monoclonal antibody, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. 



Naxitamab-gqgk is approved in combination with granulocyte-macrophage colony-stimulating factor as a treatment for pediatric patients 1 year of age and older and adult patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior treatment.



Danyelza is the trade name.



It is administered 3 times per week in an outpatient setting and is repeated every 4 weeks.



In 28 patients with primary refractory high-risk neuroblastoma, the overall response rate was 78% and the 2-year PFS rate was 50%. 



In a subset of 35 patients with relapsed neuroblastoma resistant to salvage therapy, the overall response rate was 37% and the 2-year PFS rate was 36%. 



In patients with high-risk neuroblastoma in second or later complete remission and no evidence of disease, naxitamab was given in combination with GM-CSF as maintenance therapy; resulted in a 2-year PFS rate of 52%.



Treatment with the agent in 24 patients with relapsed/refractory high-risk neuroblastoma led to a high complete response (CR) rate of 71% and an overall objective response rate (ORR) of 79%%.



Of 16 patients who were primary refractory, the overall response rate with naxitamab was 88%.



The median progression-free survival was 42 weeks.



Adverse events included: general disorders and administration site conditions (72%), pain (72%), vascular disorders (60%), hypotension (60%), respiratory, thoracic, and mediastinal disorders (44%), skin and subcutaneous tissue disorders (40%), and urticaria (40%), among others.



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