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FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy.
Kim, Geoffrey; Ison, Gwynn; McKee, Amy E; Zhang, Hui; Tang, Shenghui; Gwise, Thomas; Sridhara, Rajeshwari; Lee, Eunice; Tzou, Abraham; Philip, Reena; Chiu, Haw-Jyh; Ricks, Tiffany K; Palmby, Todd; Russell, Anne Marie; Ladouceur, Gaetan; Pfuma, Elimika; Li, Hongshan; Zhao, Liang; Liu, Qi; Venugopal, Rajesh; Ibrahim, Amna; Pazdur, Richard.
Afiliación
  • Kim G; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland. Geoffrey.Kim@fda.hhs.gov.
  • Ison G; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • McKee AE; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhang H; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Tang S; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gwise T; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sridhara R; Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Lee E; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Tzou A; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Philip R; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Chiu HJ; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ricks TK; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Palmby T; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Russell AM; New Drug Quality Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ladouceur G; New Drug Quality Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pfuma E; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Li H; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhao L; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Liu Q; Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Venugopal R; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Ibrahim A; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Office of Hematology and Oncology Products (OHOP), U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 21(19): 4257-61, 2015 Oct 01.
Article en En | MEDLINE | ID: mdl-26187614
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Ftalazinas / Piperazinas / United States Food and Drug Administration / Aprobación de Drogas / Mutación de Línea Germinal / Genes BRCA1 / Genes BRCA2 / Antineoplásicos Límite: Animals / Female / Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2015 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Ftalazinas / Piperazinas / United States Food and Drug Administration / Aprobación de Drogas / Mutación de Línea Germinal / Genes BRCA1 / Genes BRCA2 / Antineoplásicos Límite: Animals / Female / Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2015 Tipo del documento: Article