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FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
Duke, Elizabeth S; Stapleford, Liza; Drezner, Nicole; Amatya, Anup K; Mishra-Kalyani, Pallavi S; Shen, Yuan-Li; Maxfield, Kimberly; Zirkelbach, Jeanne Fourie; Bi, Youwei; Liu, Jiang; Zhang, Xinyuan; Wang, Hezhen; Yang, Yuching; Zheng, Nan; Reece, Kelie; Wearne, Emily; Glen, Jacqueline J; Ojofeitimi, Idara; Scepura, Barbara; Nair, Abhilasha; Bikkavilli, Rama Kamesh; Ghosh, Soma; Philip, Reena; Pazdur, Richard; Beaver, Julia A; Singh, Harpreet; Donoghue, Martha.
Afiliación
  • Duke ES; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Stapleford L; Center for Devices and Radiological Health, 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.
  • 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.
  • Shen YL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Maxfield K; 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.
  • Liu J; 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.
  • Wang H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Yang Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zheng N; 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.
  • Wearne E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Glen JJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ojofeitimi I; 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.
  • Nair A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bikkavilli RK; 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.
  • 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.
  • Donoghue M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 29(3): 508-512, 2023 02 01.
Article en En | MEDLINE | ID: mdl-36112541
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article