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Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development.
Duke, Elizabeth S; J Fusco, Michael; DeMoss, Patrick; Dilawari, Asma; Pamuk, Gulsum E; Boehmer, Jessica; Mixter, Bronwyn; Goldberg, Kirsten B; Kluetz, Paul; Pazdur, Richard.
  • Duke ES; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • J Fusco M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • DeMoss P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Dilawari A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pamuk GE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Boehmer J; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Mixter B; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Cancer Discov ; 12(12): 2739-2746, 2022 Dec 02.
Artículo en Inglés | MEDLINE | ID: covidwho-2153186
ABSTRACT
In 2022, cancer drug development continued to progress rapidly despite the lingering COVID-19 pandemic. Highlights of U.S. drug approvals for oncology indications this year include ongoing development in rare diseases and molecular subgroups, improved dosage optimization, and updated data for drugs granted accelerated approval, with confirmatory studies demonstrating verification of clinical benefit in some instances, as well as indication withdrawal when clinical benefit was not verified.
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Texto completo: Disponible Colección: Bases de datos internacionales Base de datos: MEDLINE Asunto principal: Pandemias / Tratamiento Farmacológico de COVID-19 Tipo de estudio: Estudio pronóstico Tópicos: Covid persistente Límite: Humanos Idioma: Inglés Revista: Cancer Discov Año: 2022 Tipo del documento: Artículo

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Texto completo: Disponible Colección: Bases de datos internacionales Base de datos: MEDLINE Asunto principal: Pandemias / Tratamiento Farmacológico de COVID-19 Tipo de estudio: Estudio pronóstico Tópicos: Covid persistente Límite: Humanos Idioma: Inglés Revista: Cancer Discov Año: 2022 Tipo del documento: Artículo