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.
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| No biomarker required3 | ||||
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) | None | + interleukin-2 (IL-2) | 1L | 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 |
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) | None | Monotherapy | 1L | 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) |
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) | None | + interleukin-2 (IL-2) | 2L 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 approvals6
Approved for any solid tumour that carries the alteration, wherever the tumour started.
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| EpCAM1 | ||||
Korjuny | Monotherapy | 2L | Malignant ascites; not eligible for further systemic anticancer therapy | |
| HER21 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
| NTRK fusion3 | ||||
Rozlytrekconditional | 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 | |
Vitrakviconditional | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Augtyroconditional | Monotherapy | Any line 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 fusion1 | ||||
Retsevmo | Monotherapy | Any line advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older | |
Label wording3
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Dinutuximab beta (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron))
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.
- Dinutuximab beta (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron))
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.
- Dinutuximab beta (Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron))
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).