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FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations.
Mathieu, Luckson N; Larkins, Erin; Akinboro, Oladimeji; Roy, Pourab; Amatya, Anup K; Fiero, Mallorie H; Mishra-Kalyani, Pallavi S; Helms, Whitney S; Myers, Claire E; Skinner, Amy M; Aungst, Stephanie; Jin, Runyan; Zhao, Hong; Xia, Huiming; Zirkelbach, Jeanne Fourie; Bi, Youwei; Li, Yangbing; Liu, Jiang; Grimstein, Manuela; Zhang, Xinyuan; Woods, Stacie; Reece, Kelie; Abukhdeir, Abdelrahmman M; Ghosh, Soma; Philip, Reena; Tang, Shenghui; Goldberg, Kirsten B; Pazdur, Richard; Beaver, Julia A; Singh, Harpreet.
Afiliação
  • Mathieu LN; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Luckson.Mathieu@fda.hhs.gov.
  • Larkins E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Akinboro O; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Roy P; 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.
  • Fiero MH; 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.
  • Helms WS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Myers CE; 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.
  • Aungst S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Jin R; 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.
  • Xia H; 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.
  • Bi Y; 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.
  • Grimstein M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Woods S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Reece K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Abukhdeir AM; Center for Device and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ghosh S; Center for Device and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Philip R; Center for Device and Radiological Health, 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.
  • Goldberg KB; Oncology Center of Excellence, 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.
  • Beaver JA; 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 ; 28(2): 249-254, 2022 01 15.
Article em En | MEDLINE | ID: mdl-34344795

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares Limite: Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article