Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (dinutuximab beta)
- Region
- 🇪🇺 EU
- Active substance
- dinutuximab beta
- Company
- Recordati Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Neuroblastoma
- CHMP opinion
- Thu 23 Mar 2017
- EU approval
- Mon 08 May 2017
- Designations
- Orphan, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/003918
- ATC
- L01FX06
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.