Dinutuximab beta
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Neuroblastoma3 | |||
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 |
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) |
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 |
Full text of section 4.1 (therapeutic indications)
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. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. 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).
Label history
20 changes to the Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) label since 2017, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes