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Therapy Name | Dinutuximab beta |
Synonyms | |
Therapy Description |
Dinutuximab beta (ch14.18/CHO) is biosimilar of the anti-GD2 antibody Unituxin (dinutuximab) produced in CHO cells, with a different glycosylation pattern than dinutuximab, which potentially induces antibody-dependent and complement-dependent cytotoxicity against GD2-expressing tumor cells, and reduces liver metastasis (PMID: 30613134, PMID: 15950727). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Dinutuximab beta | ch14.18/CHO|APN311|APN-311|APN 311|Qarziba | Dinutuximab beta (ch14.18/CHO) is biosimilar of the anti-GD2 antibody Unituxin (dinutuximab) produced in CHO cells, with a different glycosylation pattern than dinutuximab, which potentially induces antibody-dependent and complement-dependent cytotoxicity against GD2-expressing tumor cells, and reduces liver metastasis (PMID: 30613134, PMID: 15950727). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT01704716 | Phase III | Busulfan + Melphalan Carboplatin + Cisplatin + Cyclophosphamide + Etoposide + Filgrastim Cisplatin + Cyclophosphamide + Doxorubicin + Etoposide + Vincristine Sulfate Dinutuximab beta Aldesleukin + Dinutuximab beta Carboplatin + Etoposide + Melphalan Carboplatin + Cisplatin + Cyclophosphamide + Etoposide + Vincristine Sulfate | High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN) | Recruiting | ITA | GBR | FRA | ESP | BEL | AUT | AUS | 13 |
NCT04221035 | Phase III | Busulfan + Melphalan + Thiotepa Dinutuximab beta Cisplatin + Etoposide + Vindesine Dacarbazine + Doxorubicin + Ifosfamide + Vincristine Sulfate Carboplatin + Cisplatin + Cyclophosphamide + Etoposide + Vincristine Sulfate Busulfan + Melphalan | High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) (HR-NBL2) | Recruiting | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUS | 11 |