{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T02:05:16Z","timestamp":1779242716304,"version":"3.51.4"},"reference-count":33,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2016,2,25]],"date-time":"2016-02-25T00:00:00Z","timestamp":1456358400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2016,5]]},"abstract":"<jats:p>Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, dosage and administration, and formulary considerations for dinutuximab. Data Sources: MEDLINE was searched (1964 to January 2016) using the terms ch14.18, dinutuximab, immunotherapy, and neuroblastoma. Other information was identified from package insert, Biologics License Application, abstracts, news releases, and ClinicalTrials.gov. Study Selection and Data Extraction: Identified English-language articles were reviewed. Selected studies included phase I through III. Data Synthesis: High-risk neuroblastoma is primarily a childhood cancer with 5-year survival rates of 40% to 50%. Treatment for high-risk neuroblastoma includes induction chemotherapy, surgery, myeloablative chemotherapy with autologous hematopoietic stem cell transplant, and radiation therapy. For patients achieving clinical remission, limited treatments exist for preventing relapse. Dinutuximab is a chimeric, human-murine, anti-GD2 monoclonal antibody approved in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), aldesleukin (interleukin-2 [IL-2]), and isotretinoin (13-cis-retinoic acid [RA]) for maintenance treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to first-line multiagent, multimodality therapy. In phase III trials, dinutuximab increased 2-year event-free survival and overall survival when compared to standard treatment. Severe adverse effects of dinutuximab include pain, hypersensitivity reactions, capillary leak syndrome, and hypotension. Conclusions: Dinutuximab is the first anti-GD2 monoclonal antibody approved in combination with GM-CSF, IL-2, and RA for maintenance treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to first-line multiagent, multimodality therapy. Ongoing research will determine if dinutuximab could be used earlier in treatment, in nonresponders to initial therapies, in combination with chemotherapy, or in other cancers.<\/jats:p>","DOI":"10.1177\/1060028016632013","type":"journal-article","created":{"date-parts":[[2016,2,25]],"date-time":"2016-02-25T22:49:48Z","timestamp":1456440588000},"page":"416-422","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":58,"title":["Dinutuximab"],"prefix":"10.1177","volume":"50","author":[{"given":"Cady","family":"Ploessl","sequence":"first","affiliation":[{"name":"Virginia Commonwealth University Health System\/Medical College of Virginia Hospitals, Richmond, VA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alice","family":"Pan","sequence":"additional","affiliation":[{"name":"Virginia Commonwealth University Health System\/Medical College of Virginia Hospitals, Richmond, VA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathryn T.","family":"Maples","sequence":"additional","affiliation":[{"name":"Virginia Commonwealth University Health System\/Medical College of Virginia Hospitals, Richmond, VA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Denise K.","family":"Lowe","sequence":"additional","affiliation":[{"name":"Virginia Commonwealth University Health System\/Medical College of Virginia Hospitals, Richmond, VA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2016,2,25]]},"reference":[{"key":"bibr1-1060028016632013","unstructured":"National Cancer Institute. Neuroblastoma Treatment: For Health Professionals (PDQ\u00ae). Bethesda, MD: National Cancer Institute; 2015. http:\/\/www.cancer.gov\/types\/neuroblastoma\/hp\/neuroblastoma-treatment-pdq.\u2009Accessed September 20,2015."},{"key":"bibr2-1060028016632013","unstructured":"National Cancer Institute. SEER Cancer Statistics Review, 1975-2010. Bethesda, MD: National Cancer Institute; 2013. http:\/\/seer.cancer.gov\/archive\/csr\/1975_2010\/.\u2009Accessed September 20, 2015."},{"key":"bibr3-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.05.571"},{"key":"bibr4-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.59.4648"},{"key":"bibr5-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1097\/MPH.0000000000000308"},{"key":"bibr6-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.24452"},{"key":"bibr7-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa060185"},{"key":"bibr8-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.6296"},{"key":"bibr9-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199910143411601"},{"key":"bibr10-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.13.8925"},{"key":"bibr11-1060028016632013","unstructured":"US Food and Drug Administration. FDA approves first therapy for high-risk neuroblastoma. http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm437460.htm. Accessed November 16, 2015."},{"key":"bibr12-1060028016632013","unstructured":"Unituxin (dinutuximab) injection [product information]. Silver Spring, MD: United Therapeutics Corp; 2015."},{"key":"bibr13-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1080\/07357900601130763"},{"key":"bibr14-1060028016632013","first-page":"5914","volume":"44","author":"Schulz G","year":"1984","journal-title":"Cancer Res"},{"key":"bibr15-1060028016632013","doi-asserted-by":"publisher","DOI":"10.2174\/156800910791054167"},{"key":"bibr16-1060028016632013","first-page":"5309","volume":"56","author":"Hakomori S.","year":"1996","journal-title":"Cancer Res"},{"key":"bibr17-1060028016632013","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.144.4.1382"},{"key":"bibr18-1060028016632013","first-page":"58","volume":"77","author":"Dallegri F","year":"1989","journal-title":"Clin Exp Immunol"},{"key":"bibr19-1060028016632013","first-page":"5234","volume":"50","author":"Hank JA","year":"1990","journal-title":"Cancer Res"},{"key":"bibr20-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1007\/BF01526552"},{"key":"bibr21-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-014-2575-9"},{"key":"bibr22-1060028016632013","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s40265-014-0319-0","volume":"75","author":"Dhillon S.","year":"2015","journal-title":"Drugs"},{"key":"bibr23-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1016\/0959-8049(94)00413-Y"},{"key":"bibr24-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.6.2169"},{"key":"bibr25-1060028016632013","first-page":"513a","volume":"16","author":"Yu AL","year":"1997","journal-title":"Proc Am Soc Clin Oncol"},{"key":"bibr26-1060028016632013","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0911123"},{"key":"bibr27-1060028016632013","unstructured":"Center for Drug Evaluation and Research. 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