Therapy Detail

Therapy Name Dinutuximab
Therapy Description

Unituxin (dinutuximab) is a monoclonal antibody that targets B4GALNT1 (GD2) and increases antibody-dependent and complement-dependent cytotoxicity against GD2-expressing tumor cells (NCI Drug Dictionary). Unituxin (dinutuximab) is FDA approved for pediatric high-risk neuroblastoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Dinutuximab Unituxin MOAB Ch14.18 Unituxin (dinutuximab) is a monoclonal antibody that targets B4GALNT1 (GD2) and increases antibody-dependent and complement-dependent cytotoxicity against GD2-expressing tumor cells (NCI Drug Dictionary). Unituxin (dinutuximab) is FDA approved for pediatric high-risk neuroblastoma (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown neuroblastoma not applicable Dinutuximab FDA approved Actionable In a Phase III trial supporting FDA approval, Unituxin (dinutuximab) in combination with Sargramostim, Aldesleukin, and 13-cis-retinoic acid resulted in improved median event-free survival (HR = 0.57) and overall survival (HR = 0.58) compared to control group in high-risk pediatric neuroblastoma patients (PMID: 26917818). 26917818
Clinical Trial Phase Therapies Title Recruitment Status
NCT01767194 Phase II Dinutuximab Temsirolimus Temozolomide + Irinotecan Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients With Refractory or Relapsed Neuroblastoma Completed
NCT03126916 Phase III Doxorubicin 131I-MIBG Sargramostim Etoposide Melphalan Busulfan Isotretinoin Vincristine Cisplatin Cyclophosphamide Thiotepa Crizotinib dexrazoxane Carboplatin Aldesleukin Topotecan Dinutuximab Iobenguane I-131 or Crizotinib and Standard Therapy in Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma or Ganglioneuroblastoma Recruiting