{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1361699995563053440.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.1158/1078-0432.ccr-15-0612"}},{"identifier":{"@type":"URI","@value":"https://aacrjournals.org/clincancerres/article-pdf/21/18/4035/2026114/4035.pdf"}}],"dc:title":[{"@value":"FDA Approval: Blinatumomab"}],"description":[{"type":"abstract","notation":[{"@value":"<jats:title>Abstract</jats:title>\n                  <jats:p>On December 3, 2014, the FDA granted accelerated approval of blinatumomab (Blincyto; Amgen, Inc.) for treatment of Philadelphia chromosome–negative relapsed or refractory precursor B-cell acute lymphoblastic leukemia (R/R ALL). Blinatumomab is a recombinant murine protein that acts as a bispecific CD19-directed CD3 T-cell engager. The basis for the approval was a single-arm trial with 185 evaluable adults with R/R ALL. The complete remission (CR) rate was 32% [95% confidence interval (CI), 26%–40%], and the median duration of response was 6.7 months. A minimal residual disease response was achieved by 31% (95% CI, 25%–39%) of all patients. Cytokine release syndrome and neurologic events were serious toxicities that occurred. Other common (&gt;20%) adverse reactions were pyrexia, headache, edema, febrile neutropenia, nausea, tremor, and rash. Neutropenia, thrombocytopenia, and elevated transaminases were the most common (&gt;10%) laboratory abnormalities related to blinatumomab. A randomized trial is required in order to confirm clinical benefit. Clin Cancer Res; 21(18); 4035–9. ©2015 AACR.</jats:p>"}]}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1381699995563053441","@type":"Researcher","foaf:name":[{"@value":"Donna Przepiorka"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053449","@type":"Researcher","foaf:name":[{"@value":"Chia-Wen Ko"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053443","@type":"Researcher","foaf:name":[{"@value":"Albert Deisseroth"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053312","@type":"Researcher","foaf:name":[{"@value":"Carolyn L. Yancey"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053442","@type":"Researcher","foaf:name":[{"@value":"Reyes Candau-Chacon"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053450","@type":"Researcher","foaf:name":[{"@value":"Haw-Jyh Chiu"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053444","@type":"Researcher","foaf:name":[{"@value":"Brenda J. Gehrke"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053454","@type":"Researcher","foaf:name":[{"@value":"Candace Gomez-Broughton"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053313","@type":"Researcher","foaf:name":[{"@value":"Robert C. Kane"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053447","@type":"Researcher","foaf:name":[{"@value":"Susan Kirshner"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053452","@type":"Researcher","foaf:name":[{"@value":"Nitin Mehrotra"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053440","@type":"Researcher","foaf:name":[{"@value":"Tiffany K. Ricks"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053451","@type":"Researcher","foaf:name":[{"@value":"Deborah Schmiel"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053445","@type":"Researcher","foaf:name":[{"@value":"Pengfei Song"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053314","@type":"Researcher","foaf:name":[{"@value":"Ping Zhao"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053448","@type":"Researcher","foaf:name":[{"@value":"Qing Zhou"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053453","@type":"Researcher","foaf:name":[{"@value":"Ann T. Farrell"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]},{"@id":"https://cir.nii.ac.jp/crid/1381699995563053446","@type":"Researcher","foaf:name":[{"@value":"Richard Pazdur"}],"jpcoar:affiliationName":[{"@value":"Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland."}]}],"publication":{"publicationIdentifier":[{"@type":"PISSN","@value":"10780432"},{"@type":"EISSN","@value":"15573265"}],"prism:publicationName":[{"@value":"Clinical Cancer Research"}],"dc:publisher":[{"@value":"American Association for Cancer Research (AACR)"}],"prism:publicationDate":"2015-09-14","prism:volume":"21","prism:number":"18","prism:startingPage":"4035","prism:endingPage":"4039"},"reviewed":"false","url":[{"@id":"https://aacrjournals.org/clincancerres/article-pdf/21/18/4035/2026114/4035.pdf"}],"createdAt":"2015-09-15","modifiedAt":"2022-06-11","relatedProduct":[{"@id":"https://cir.nii.ac.jp/crid/1360567186322858240","@type":"Article","resourceType":"学術雑誌論文(journal article)","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@value":"A T-cell–engaging B7-H4/CD3-bispecific Fab-scFv Antibody Targets Human Breast Cancer"}]},{"@id":"https://cir.nii.ac.jp/crid/1360588381051793024","@type":"Article","resourceType":"学術雑誌論文(journal article)","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@value":"Cancer immunotherapy in progress—an overview of the past 130 years"}]},{"@id":"https://cir.nii.ac.jp/crid/1360869855105289216","@type":"Article","resourceType":"学術雑誌論文(journal article)","relationType":["isReferencedBy"],"jpcoar:relatedTitle":[{"@value":"Development of DNA aptamers universally bound to single-chain fragment variables and their applications in bioprocess monitoring"}]}],"dataSourceIdentifier":[{"@type":"CROSSREF","@value":"10.1158/1078-0432.ccr-15-0612"},{"@type":"CROSSREF","@value":"10.1158/1078-0432.ccr-17-3123_references_DOI_9yODpXNeaHqf6YyF7eN5e9Ag1k0"},{"@type":"CROSSREF","@value":"10.1093/intimm/dxaf002_references_DOI_9yODpXNeaHqf6YyF7eN5e9Ag1k0"},{"@type":"CROSSREF","@value":"10.1016/j.bios.2024.116511_references_DOI_9yODpXNeaHqf6YyF7eN5e9Ag1k0"}]}