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FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions.
Kim, Janice; Bradford, Diana; Larkins, Erin; Pai-Scherf, Lee H; Chatterjee, Somak; Mishra-Kalyani, Pallavi S; Wearne, Emily; Helms, Whitney S; Ayyoub, Amal; Bi, Youwei; Sun, Jielin; Charlab, Rosane; Liu, Jiang; Zhao, Hong; Liang, Dun; Ghosh, Soma; Philip, Reena; Pazdur, Richard; Theoret, Marc R; Beaver, Julia A; Singh, Harpreet.
Afiliación
  • Kim J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. janice.kim@fda.hhs.gov.
  • Bradford D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Larkins E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pai-Scherf LH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chatterjee S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Mishra-Kalyani PS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Wearne E; 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.
  • Ayyoub A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bi Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sun 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.
  • Liu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhao H; Center for Drug Evaluation and Research, 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.
  • Philip R; Center for Devices and Radiological Health, 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.
  • Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Singh H; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 27(20): 5452-5456, 2021 10 15.
Article en En | MEDLINE | ID: mdl-34045295

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Pirazoles / Piridinas / Pirimidinas / Neoplasias de la Tiroides / Aprobación de Drogas / Carcinoma Neuroendocrino / Proteínas Proto-Oncogénicas c-ret / Fusión Génica / Neoplasias Pulmonares / Mutación Tipo de estudio: Clinical_trials Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Pirazoles / Piridinas / Pirimidinas / Neoplasias de la Tiroides / Aprobación de Drogas / Carcinoma Neuroendocrino / Proteínas Proto-Oncogénicas c-ret / Fusión Génica / Neoplasias Pulmonares / Mutación Tipo de estudio: Clinical_trials Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article