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FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors.
Marcus, Leigh; Donoghue, Martha; Aungst, Stephanie; Myers, Claire E; Helms, Whitney S; Shen, Guoxiang; Zhao, Hong; Stephens, Olen; Keegan, Patricia; Pazdur, Richard.
Affiliation
  • Marcus L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. leigh.marcus@fda.hhs.gov.
  • Donoghue M; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Aungst S; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Myers CE; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Helms WS; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shen G; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhao H; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Stephens O; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Keegan P; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 27(4): 928-932, 2021 02 15.
Article in En | MEDLINE | ID: mdl-32967940
Subject(s)
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Benzamides / Oncogene Proteins, Fusion / Drug Approval / Protein Kinase Inhibitors / Indazoles / Neoplasms Type of study: Prognostic_studies Limits: Humans Country/Region as subject: America do norte Language: En Journal: Clin Cancer Res Journal subject: NEOPLASIAS Year: 2021 Document type: Article Country of publication: United States
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Benzamides / Oncogene Proteins, Fusion / Drug Approval / Protein Kinase Inhibitors / Indazoles / Neoplasms Type of study: Prognostic_studies Limits: Humans Country/Region as subject: America do norte Language: En Journal: Clin Cancer Res Journal subject: NEOPLASIAS Year: 2021 Document type: Article Country of publication: United States