# Neuroblastoma

The EU has approved 3 indications of 1 drug in neuroblastoma. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Dinutuximab beta](https://oncolabels.com/drugs/dinutuximab-beta) (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)) | None | + interleukin-2 (IL-2) | 1st line | After induction chemotherapy, myeloablative therapy and stem cell transplantation; Aged 12 months and above; received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation; have not achieved a complete response after first-line therapy |
| [Dinutuximab beta](https://oncolabels.com/drugs/dinutuximab-beta) (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)) | None | Monotherapy | 1st line | After induction chemotherapy with at least a partial response, followed by myeloablative therapy and stem cell transplantation; High-risk neuroblastoma; aged 12 months and above; achieved at least a partial response to induction chemotherapy; in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2) |
| [Dinutuximab beta](https://oncolabels.com/drugs/dinutuximab-beta) (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)) | None | + interleukin-2 (IL-2) | 2nd line, advanced | After prior systemic therapy (history of relapsed or refractory neuroblastoma); Aged 12 months and above; with or without residual disease; actively progressing disease should be stabilised by other suitable measures prior to treatment |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Dinutuximab beta** (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)), Neuroblastoma, 1st line: “Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/qarziba-epar-product-information_en.pdf)
- **Dinutuximab beta** (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)), Neuroblastoma, 2nd line, advanced: “Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/qarziba-epar-product-information_en.pdf)
- **Dinutuximab beta** (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)), Neuroblastoma, 1st line: “In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/qarziba-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/neuroblastoma