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FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation-Positive Low-Grade Glioma.
Barbato, Michael I; Nashed, Jeannette; Bradford, Diana; Ren, Yi; Khasar, Sachia; Miller, Claudia P; Zolnik, Banu S; Zhao, Hong; Li, Yangbing; Bi, Youwei; Shord, Stacy S; Amatya, Anup K; Mishra-Kalyani, Pallavi S; Scepura, Barbara; Al-Matari, Raniya A; Pazdur, Richard; Kluetz, Paul G; Donoghue, Martha; Singh, Harpreet; Drezner, Nicole.
Afiliação
  • Barbato MI; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Nashed J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bradford D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ren Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Khasar S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Miller CP; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zolnik BS; 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.
  • Li Y; 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.
  • Shord SS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Amatya AK; 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.
  • Scepura B; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Al-Matari RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; 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.
  • Donoghue M; 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.
  • Drezner N; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 30(2): 263-268, 2024 01 17.
Article em En | MEDLINE | ID: mdl-37610803

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Piridonas / Glioma / Imidazóis Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Piridonas / Glioma / Imidazóis Idioma: En Ano de publicação: 2024 Tipo de documento: Article