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Trends in the approval of cancer therapies by the FDA in the twenty-first century.
Scott, Emma C; Baines, Andrea C; Gong, Yutao; Moore, Rodney; Pamuk, Gulsum E; Saber, Haleh; Subedee, Ashim; Thompson, Matthew D; Xiao, Wenming; Pazdur, Richard; Rao, V Ashutosh; Schneider, Julie; Beaver, Julia A.
Afiliación
  • Scott EC; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. emma.scott@fda.hhs.gov.
  • Baines AC; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Gong Y; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Moore R; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Pamuk GE; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Saber H; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Subedee A; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Thompson MD; National Cancer Institute, Rockville, MD, USA.
  • Xiao W; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Pazdur R; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Rao VA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Schneider J; Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
  • Beaver JA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Nat Rev Drug Discov ; 22(8): 625-640, 2023 08.
Article en En | MEDLINE | ID: mdl-37344568
ABSTRACT
The cancer treatment landscape has changed dramatically since the turn of the century, resulting in substantial improvements in outcomes for patients. This Review summarizes trends in the approval of oncology therapeutic products by the United States Food and Drug Administration (FDA) from January 2000 to October 2022, based on a categorization of these products by their mechanism of action and primary target. Notably, the rate of oncology indication approvals has increased in this time, driven by approvals for targeted therapies, as has the rate of introduction of new therapeutic approaches. Kinase inhibitors are the dominant product class by number of approved products and indications, yet immune checkpoint inhibitors have the second most approvals despite not entering the market until 2011. Other trends include a slight increase in the share of approvals for biomarker-defined populations and the emergence of tumour-site-agnostic approvals. Finally, we consider the implications of the trends for the future of oncology therapeutic product development, including the impact of novel therapeutic approaches and technologies.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias / Antineoplásicos Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Nat Rev Drug Discov Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias / Antineoplásicos Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Nat Rev Drug Discov Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos