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FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA-Mutated Metastatic Castrate-Resistant Prostate Cancer.
Anscher, Mitchell S; Chang, Elaine; Gao, Xin; Gong, Yutao; Weinstock, Chana; Bloomquist, Erik; Adeniyi, Oluseyi; Charlab, Rosane; Zimmerman, Sarah; Serlemitsos-Day, Maritsa; Ning, Yang Min; Mayrosh, Ruth; Fuller, Barbara; Trentacosti, Ann Marie; Gallagher, Pamela; Bijwaard, Karen; Philip, Reena; Ghosh, Soma; Fahnbulleh, Frances; Diggs, Felicia; Arora, Shaily; Goldberg, Kirsten B; Tang, Shenghui; Amiri-Kordestani, Laleh; Pazdur, Richard; Ibrahim, Amna; Beaver, Julia A.
Afiliación
  • Anscher MS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Chang E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Gao X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Gong Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Weinstock C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bloomquist E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Adeniyi O; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Charlab R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zimmerman S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Serlemitsos-Day M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ning YM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Mayrosh R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Fuller B; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Trentacosti AM; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Gallagher P; Center for Devices and Radiologic Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bijwaard K; Center for Devices and Radiologic Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Philip R; Center for Devices and Radiologic Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ghosh S; Center for Devices and Radiologic Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Fahnbulleh F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Diggs F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Arora S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ibrahim A; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Oncologist ; 26(2): 139-146, 2021 02.
Article en En | MEDLINE | ID: mdl-33145877

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Neoplasias de la Próstata Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Oncologist Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Neoplasias Ováricas / Neoplasias de la Próstata Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Oncologist Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos