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FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer.
Shah, Mirat; Wedam, Suparna; Cheng, Joyce; Fiero, Mallorie H; Xia, Huiming; Li, Fang; Fan, Jianghong; Zhang, Xinyuan; Yu, Jingyu; Song, Pengfei; Chen, Wei; Ricks, Tiffany K; Chen, Xiao Hong; Goldberg, Kirsten B; Gong, Yutao; Pierce, William F; Tang, Shenghui; Theoret, Marc R; Pazdur, Richard; Amiri-Kordestani, Laleh; Beaver, Julia A.
Afiliação
  • Shah M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. mirat.shah@fda.hhs.gov.
  • Wedam S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Cheng J; 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.
  • Xia H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Li F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Fan 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.
  • Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Song P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chen W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chen XH; 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.
  • Gong Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pierce WF; 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.
  • Theoret MR; 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.
  • Amiri-Kordestani L; Center for Drug Evaluation and Research, 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.
Clin Cancer Res ; 27(5): 1220-1226, 2021 03 01.
Article em En | MEDLINE | ID: mdl-33055172

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Oxazóis / Piridinas / Quinazolinas / Neoplasias da Mama / Aprovação de Drogas / Receptor ErbB-2 Tipo de estudo: Clinical_trials Limite: Female / Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2021 Tipo de documento: Article País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Oxazóis / Piridinas / Quinazolinas / Neoplasias da Mama / Aprovação de Drogas / Receptor ErbB-2 Tipo de estudo: Clinical_trials Limite: Female / Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2021 Tipo de documento: Article País de publicação: Estados Unidos