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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.
Article in English | 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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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / COVID-19 Drug Treatment Type of study: Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Cancer Discov Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / COVID-19 Drug Treatment Type of study: Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Cancer Discov Year: 2022 Document Type: Article