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FDA approval: siltuximab for the treatment of patients with multicentric Castleman disease.
Deisseroth, Albert; Ko, Chia-Wen; Nie, Lei; Zirkelbach, Jeanne F; Zhao, Liang; Bullock, Julie; Mehrotra, Nitin; Del Valle, Pedro; Saber, Haleh; Sheth, Christopher; Gehrke, Brenda; Justice, Robert; Farrell, Ann; Pazdur, Richard.
Afiliação
  • Deisseroth A; Office of Hematology and Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Albert.Deisseroth@fda.hhs.gov.
  • Ko CW; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Nie L; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zirkelbach JF; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhao L; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bullock J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Mehrotra N; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Del Valle P; Office of Hematology and Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Saber H; Office of Hematology and Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sheth C; Office of Hematology and Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gehrke B; Office of Hematology and Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Justice R; Office of Hematology and Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Farrell A; Office of Hematology and Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Office of Hematology and Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 21(5): 950-4, 2015 Mar 01.
Article em En | MEDLINE | ID: mdl-25601959

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Hiperplasia do Linfonodo Gigante / Aprovação de Drogas / Anticorpos Monoclonais / Antineoplásicos Tipo de estudo: Clinical_trials / Diagnostic_studies Limite: Adult / Aged / Animals / Humans / Middle aged País/Região como assunto: America do norte Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2015 Tipo de documento: Article País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Hiperplasia do Linfonodo Gigante / Aprovação de Drogas / Anticorpos Monoclonais / Antineoplásicos Tipo de estudo: Clinical_trials / Diagnostic_studies Limite: Adult / Aged / Animals / Humans / Middle aged País/Região como assunto: America do norte Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2015 Tipo de documento: Article País de publicação: Estados Unidos