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FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer.
Gao, Jennifer J; Osgood, Christy L; Gong, Yutao; Zhang, Hui; Bloomquist, Erik W; Jiang, Xiling; Qiu, Junshan; Yu, Jingyu; Song, Pengfei; Rahman, Nam Atiqur; Chiu, Haw-Jyh; Ricks, Tiffany K; Rizvi, Fatima; Hou, Sherry; Wilson, Willie; Abukhdeir, Abde M; Seidman, Jeffrey; Ghosh, Soma; Philip, Reena; Pierce, William F; Bhatnagar, Vishal; Kluetz, Paul G; Pazdur, Richard; Beaver, Julia A; Amiri-Kordestani, Laleh.
Afiliación
  • Gao JJ; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland. jennifer.gao@fda.hhs.gov.
  • Osgood CL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gong Y; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhang H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bloomquist EW; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Jiang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Qiu J; 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.
  • Rahman NA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chiu HJ; 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.
  • Rizvi F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Hou S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Wilson W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Abukhdeir AM; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Seidman J; 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.
  • Pierce WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bhatnagar V; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz PG; 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.
  • Beaver JA; 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.
Clin Cancer Res ; 27(8): 2126-2129, 2021 04 15.
Article en En | MEDLINE | ID: mdl-33188141

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Terapia Neoadyuvante Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Terapia Neoadyuvante Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos