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FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.
Bhatnagar, Vishal; Gormley, Nicole J; Luo, Lola; Shen, Yuan Li; Sridhara, Rajeshwari; Subramaniam, Sriram; Shen, Guoxiang; Ma, Lian; Shord, Stacy; Goldberg, Kirsten B; Farrell, Ann T; McKee, Amy E; Pazdur, Richard.
Affiliation
  • Bhatnagar V; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA vishal.bhatnagar@fda.hhs.gov.
  • Gormley NJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Luo L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Shen YL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Sridhara R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Subramaniam S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Shen G; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ma L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Shord S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Goldberg KB; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Farrell AT; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • McKee AE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Oncologist ; 22(11): 1347-1353, 2017 11.
Article in En | MEDLINE | ID: mdl-28904172
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Full text: 1 Collection: 01-internacional Health context: 3_ND / 4_TD / 6_ODS3_enfermedades_notrasmisibles Database: MEDLINE Main subject: Drug Resistance, Neoplasm / Antibodies, Monoclonal / Multiple Myeloma Type of study: Clinical_trials Limits: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Country/Region as subject: America do norte Language: En Journal: Oncologist Year: 2017 Document type: Article
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Health context: 3_ND / 4_TD / 6_ODS3_enfermedades_notrasmisibles Database: MEDLINE Main subject: Drug Resistance, Neoplasm / Antibodies, Monoclonal / Multiple Myeloma Type of study: Clinical_trials Limits: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Country/Region as subject: America do norte Language: En Journal: Oncologist Year: 2017 Document type: Article