Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma

Inclusion Criteria:

1)Confirmed diagnosis of high-risk NB 2)1 year of age or above 3)Patient or parent/guardian must provide written informed consent to participate 4)If patient is sexually active, the patient agrees to use effective contraception 5)Confirmed negative urine pregnancy test for sexually active female of child-bearing potential (post-menarche)

Exclusion Criteria:

1. Significant organ toxicity

2. Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSFor its s components.

3. Patient is pregnant, planning to become pregnant (while being treated withnaxitamab) or is currently breastfeeding

4. Patient will undergo treatment with another investigational drug, whilst beingtreated with naxitamab or has received another investigational drug within the 4weeks prior to commencing treatment with naxitamab

5. Patient is either eligible and able to participate in or is currently participatingin an active interventional Y-mAbs sponsored clinical trial with naxitamab withinthe indication applied for

6. Patient is unable to comply with the naxitamab treatment or has a medical conditionthat would potentially increase the severity of the toxicities experienced fromnaxitamab treatment at the discretion of the treating physician

7. Left ventricular ejection fraction of <50% by echocardiography OR other clinicallyrelevant cardiac disorders at the discretion of the investigator

8. Inadequate pulmonary function defined as evidence of dyspnea at rest, exerciseintolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry < 94% and/or abnormal pulmonary function tests if these assessments are clinicallyindicated Applicable for treatment with naxitamab in combination with GM-CSF only:

9. Patient has active progression of the NB disease

10. Patient has active NB disease at primary site or soft-tissue metastasis

11. Patient has known CNS metastases when initiating naxitamab treatment