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FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions.
Bradford, Diana; Larkins, Erin; Mushti, Sirisha L; Rodriguez, Lisa; Skinner, Amy M; Helms, Whitney S; Price, Lauren S L; Zirkelbach, Jeanne Fourie; Li, Yangbing; Liu, Jiang; Charlab, Rosane; Turcu, Francisca Reyes; Liang, Dun; Ghosh, Soma; Roscoe, Donna; Philip, Reena; Zack-Taylor, Autumn; Tang, Shenghui; Kluetz, Paul G; Beaver, Julia A; Pazdur, Richard; Theoret, Marc R; Singh, Harpreet.
Afiliação
  • Bradford D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. diana.bradford@fda.hhs.gov.
  • Larkins E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Mushti SL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rodriguez L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Skinner AM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Helms WS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Price LSL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zirkelbach JF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Li Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Liu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Charlab R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Turcu FR; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Liang D; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ghosh S; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Roscoe D; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Philip R; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zack-Taylor A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz PG; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Beaver JA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Singh H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 27(8): 2130-2135, 2021 04 15.
Article em En | MEDLINE | ID: mdl-33239432
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Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Pirazóis / Piridinas / Neoplasias da Glândula Tireoide / Protocolos de Quimioterapia Combinada Antineoplásica / Inibidores de Proteínas Quinases / Neoplasias Pulmonares Tipo de estudo: Clinical_trials Limite: Adult / Child / Humans País como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
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Texto completo: 1 Eixos temáticos: Pesquisa_clinica Base de dados: MEDLINE Assunto principal: Pirazóis / Piridinas / Neoplasias da Glândula Tireoide / Protocolos de Quimioterapia Combinada Antineoplásica / Inibidores de Proteínas Quinases / Neoplasias Pulmonares Tipo de estudo: Clinical_trials Limite: Adult / Child / Humans País como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article