What changed: High-risk neuroblastoma
Every dated change on the records linked to High-risk neuroblastoma, newest first: approvals and regulatory steps on its medicines, trials that reported, guideline versions, milestones, and when this page itself was checked. Dates come from the records; none is inferred. Orientation, not medical advice.
September 2026 · 1
2023 · 4
- 2023ApprovalEflornithine (DFMO)Eflornithine (DFMO) approved in US
Maintenance to reduce relapse risk in high-risk neuroblastoma after ≥PR to prior therapy including anti-GD2
- 2023Trial resultGD2-CART01 (Bambino Gesù phase 1/2)GD2-CART01 (Bambino Gesù phase 1/2) reported
ORR 63%, CR 33%; 3-year OS 60%.
- 2023Trial resultNMTRC003/003B (DFMO maintenance)NMTRC003/003B (DFMO maintenance) reported
EFS HR 0.
- 2023MilestoneEflornithine (DFMO)Eflornithine approved as maintenance on an external-control comparison; GD2 CAR T-cells produce remissions in relapsed disease
A milestone in how this cancer is treated.
2020 · 3
- 2020ApprovalNaxitamabNaxitamab approved in US
Relapsed/refractory high-risk neuroblastoma in bone or bone marrow with partial response, minor response or stable disease, with GM-CSF (accelerated)
- 2020Trial resultNaxitamab Study 201Naxitamab Study 201 reported
ORR 50%.
- 2020MilestoneNaxitamabNaxitamab granted accelerated approval for relapsed or refractory bone or marrow disease
A milestone in how this cancer is treated.
2019 · 1
2017 · 3
- 2017ApprovalDinutuximab (ch14.18) / dinutuximab betaDinutuximab (ch14.18) / dinutuximab beta approved in EU
Dinutuximab beta: high-risk neuroblastoma after induction/transplant; relapsed/refractory disease
- 2017Trial resultSIOPEN HR-NBL1SIOPEN HR-NBL1 reported
BuMel > CEM (EFS 50% vs 38%); IL-2 adds no benefit to anti-GD2.
- 2017MilestoneSIOPEN HR-NBL1HR-NBL1: busulfan-melphalan beats carboplatin-etoposide-melphalan
A milestone in how this cancer is treated.
2016 · 1
2015 · 2
- 2015ApprovalDinutuximab (ch14.18) / dinutuximab betaDinutuximab (ch14.18) / dinutuximab beta approved in US
High-risk neuroblastoma after at least partial response to induction, with GM-CSF, IL-2 and isotretinoin
- 2015MilestoneDinutuximab (ch14.18) / dinutuximab betaDinutuximab approved for high-risk neuroblastoma
A milestone in how this cancer is treated.