This is a summary of the European public assessment report (EPAR) for Qarziba. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Qarziba. For practical information about using Qarziba, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication 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).
Therapeutic Area (MeSH)
ATC Code
L01FX06
ATC Item
dinutuximab beta
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Dinutuximab beta | N/A | 达妥昔单抗 |
EMA Name
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Medicine Name
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Aliases
N/ANo risk management plan link.
