Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

What Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) is used for

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).

Approved use, as published by the European Medicines Agency.

What the labels mean

• Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
• Approved under exceptional circumstances: full data cannot be collected, usually because the disease is very rare.

Key facts

Brand

Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

Active substance

dinutuximab beta

Disease area

Neuroblastoma

Medicine group

Antineoplastic agents

ATC code

L01FX06

Marketing authorisation holder

Recordati Netherlands B.V.

Authorised in the EU since

2017

Official information

• Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron): European public assessment report (EPAR), product information and package leaflet, on the EMA website