Last reviewed 2026-04-20 · How we verify

Ch14.18 (DINUTUXIMAB)

Dinutuximab binds to GD2 on neuroblastoma cells and induces cell lysis via ADCC and CDC.

At a glance

Mechanism of action

Dinutuximab targets the glycolipid GD2, which is found on neuroblastoma cells and some normal cells. By binding to GD2, it triggers the immune system to destroy these cells through two mechanisms: ADCC and CDC.

Approved indications

• Neuroblastoma

Boxed warnings

• WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication. Immediately interrupt for severe infusion reactions and permanently discontinue for anaphylaxis [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.1) ] . Neurotoxicity: Unituxin causes severe neuropathic pain. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. Severe peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma. Severe peripheral motor neuropathy has also been reported. Discontinue for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ] . Infusion Reactions Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated with Unituxin. Administer required prehydration and premedication including antihistamines prior to each Unituxin infusion. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of each Unituxin infusion. Immediately interrupt Unituxin for severe infusion reactions and permanently discontinue Unituxin for anaphylaxis ( 2.2, 2.3, 5.1 ). Neurotoxicity Unituxin causes serious neurologic adverse reactions including severe neuropathic pain and peripheral neuropathy. Severe neuropathic pain occurs in the majority of patients. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. In clinical studies of patients with high-risk neuroblastoma, Grade 3 peripheral sensory neuropathy occurred in 2% to 9% of patients. In clinical studies of Unituxin and related GD2-binding antibodies, severe motor neuropathy has occurred. Resolution of motor neuropathy did not occur in all cases. Discontinue Unituxin for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy ( 2.2, 2.3, 5.2 ).

Common side effects

• pain
• pyrexia
• thrombocytopenia
• lymphopenia
• infusion reactions
• hypotension
• hyponatremia
• increased alanine aminotransferase
• anemia
• vomiting
• diarrhea
• hypokalemia

Key clinical trials

• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
• Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (PHASE1)
• Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (PHASE1,PHASE2)
• NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (PHASE2)
• Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells (PHASE1)
• Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (PHASE3)
• A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma (PHASE1,PHASE2)
• Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (PHASE3)

Primary sources

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