# Dinutuximab beta

Dinutuximab beta (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Recordati Netherlands B.V.) has 3 EU-approved indications in 1 tumour type.

## Approved indications

### Neuroblastoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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 |
| 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) |
| 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 |

## Products

### Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

- Company: Recordati Netherlands B.V.
- Target: Anti-GD2 monoclonal antibody
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX06
- EU approval: 8 May 2017
- Label revised: 29 Oct 2026
- Status: exceptional circumstances, orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/qarziba-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/qarziba-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/qarziba

Mechanism (SmPC section 5.1): Dinutuximab beta is a chimeric monoclonal IgG1 antibody specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2) overexpressed on neuroblastoma cells.

## 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/drugs/dinutuximab-beta