Dinutuximab: A Review in High-Risk Neuroblastoma

Targeted Oncology

Volumn 11, Issue 2, 2016, Pages 247-253

  Hoy, Sheridan M ^a  

^a SPRINGER   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; DINUTUXIMAB; ISOTRETINOIN; CH14.18 MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY;

ANEMIA; ARTICLE; CANCER IMMUNOTHERAPY; CANCER SURVIVAL; CAPILLARY LEAK SYNDROME; DIARRHEA; DRUG APPROVAL; DRUG BINDING; DRUG BIOAVAILABILITY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EVENT FREE SURVIVAL; FEVER; HUMAN; HYPOKALEMIA; HYPONATREMIA; HYPOTENSION; INFUSION REACTION; LYMPHOCYTOPENIA; MULTICENTER STUDY (TOPIC); NEUROBLASTOMA; NONHUMAN; OVERALL SURVIVAL; PAIN; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; SURVIVAL RATE; THROMBOCYTOPENIA; ANIMAL;

ANIMALS; ANTIBODIES, MONOCLONAL; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; NEUROBLASTOMA; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84958752959     PISSN: 17762596     EISSN: 1776260X     Source Type: Journal    
DOI: 10.1007/s11523-016-0420-2     Document Type: Article

References (21)

1. Parsons K, Bernhardt B, Strickland B. Targeted immunotherapy for high-risk neuroblastoma: the role of monoclonal antibodies. Ann Pharmacother. 2013;47(2):210–8.
2. European Medicines Agency. Unituxin: assessment report. 2015. http://www.ema.europa.eu/ema/. Accessed 15 Jan 2016.
3. Maris JM. Recent advances in neuroblastoma. N Engl J Med. 2010;362(23):2202–11.
4. Pinto NR, Applebaum MA, Volchenboum SL, et al. Advances in risk classification and treatment strategies for neuroblastoma. J Clin Oncol. 2015;33(27):3008–17.
5. Matthay KK, Villablanca JG, Seeger RC, et al. Treatment of high-risk neuroblastoma with intensive chemotherapy, radiotherapy, autologous bone marrow transplantation, and 13-cis-retinoic acid. Children’s Cancer Group. N Engl J Med. 1999;341(16):1165–73.
6. Desai AV, Fox E, Smith LM, et al. Pharmacokinetics of the chimeric anti-GD2 antibody, ch14.18, in children with high-risk neuroblastoma. Cancer Chemother Pharmacol. 2014;74(5):1047–55.
7. Marachelian A, Desai A, Balis F, et al. Comparative pharmacokinetics, safety, and tolerability of two sources of ch14.18 in pediatric patients with high-risk neuroblastoma following myeloablative therapy. Cancer Chemother Pharmacol. 2016. doi:10.1007/s00280-015-2955-9.
8. United Therapeutics Europe Ltd. Unituxin 3.5 mg/mL concentrate for solution for infusion: EU summary of product characteristics. 2015. http://www.ema.europa.eu/ema/. Accessed 15 Jan 2016.
9. United Therapeutics Corp. Unituxin™ (dinutuximab) injection, for intravenous use: US prescribing information. 2015. http://www.fda.gov/. Accessed 15 Jan 2016.
10. Barker E, Mueller BM, Handgretinger R, et al. Effect of a chimeric anti-ganglioside GD2 antibody on cell-mediated lysis of human neuroblastoma cells. Cancer Res. 1991;51(1):144–9.
11. Handgretinger R, Anderson K, Lang P. A phase I study of human/mouse chimeric antiganglioside GD2 antibody ch14.18 in patients with neuroblastoma. Eur J Cancer. 1995;31a(2):261–7.
12. Ozkaynak MF, Sondel PM, Krailo MD, et al. Phase I study of chimeric human/murine anti-ganglioside G(D2) monoclonal antibody (ch14.18) with granulocyte-macrophage colony-stimulating factor in children with neuroblastoma immediately after hematopoietic stem-cell transplantation: a Children’s Cancer Group Study. J Clin Oncol. 2000;18(24):4077–85.
13. Gilman AL, Ozkaynak MF, Matthay KK, et al. Phase I study of ch14.18 with granulocyte-macrophage colony-stimulating factor and interleukin-2 in children with neuroblastoma after autologous bone marrow transplantation or stem-cell rescue: a report from the Children’s Oncology Group. J Clin Oncol. 2009;27(1):85–91.
14. Yu AL, Uttenreuther-Fischer MM, Huang CS, et al. Phase I trial of a human-mouse chimeric anti-disialoganglioside monoclonal antibody ch14.18 in patients with refractory neuroblastoma and osteosarcoma. J Clin Oncol. 1998;16(6):2169–80.
15. Yu AL, Gilman AL, Ozkaynak MF, et al. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010;363(14):1324–34.
16. Ozkaynak MF, Gilman AL, Yu AL, et al. A comprehensive safety trial of chimeric antibody 14.18 (ch14.18) with GM-CSF, IL-2, and isotretinoin in high-risk neuroblastoma patients following myeloablative therapy: a Children’s Oncology Group study [abstract no. 10044]. J Clin Oncol. 2014;32(5 Suppl 1).
17. US National Institutes of Health. ClinicalTrials.gov. 2015. http://www.clinicaltrials.gov/. Accessed 15 Jan 2016.
18. US FDA Center for Drug Evaluation and Research. Medical review: Unituxin (dinutuximab). 2015. http://www.fda.gov/. Accessed 15 Jan 2016.
19. US FDA Center for Drug Evaluation and Research. Statistical review: Unituxin (dinutuximab). 2015. http://www.fda.gov/. Accessed 15 Jan 2016.
20. US FDA Center for Drug Evaluation and Research. Summary review: Unituxin (dinutuximab). 2015. http://www.fda.gov/. Accessed 15 Jan 2016.
21. US FDA. FDA approves first therapy for high-risk neuroblastoma [media release]. 10 Mar 2015. http://www.fda.gov/.