Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development.

Humans Pandemics Medical Oncology Drug Development Drug Approval COVID-19 Drug Treatment

Journal

Cancer discovery
ISSN: 2159-8290
Titre abrégé: Cancer Discov
Pays: United States
ID NLM: 101561693

Informations de publication

Date de publication:
02 12 2022
Historique:
entrez: 2 12 2022
pubmed: 3 12 2022
medline: 6 12 2022
Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1158/2159-8290.CD-22-1185 PMID: 36458428
pubmed: 36458428
pii: 711156
doi: 10.1158/2159-8290.CD-22-1185
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2739-2746

Informations de copyright

©2022 American Association for Cancer Research.

Auteurs

Elizabeth S Duke (ES)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-3361-1436

Michael J Fusco (M)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-5883-7466

Patrick DeMoss (P)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-6400-8501

Asma Dilawari (A)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-5706-9138

Gulsum E Pamuk (GE)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-2299-3758

Jessica Boehmer (J)

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-0744-8241

Bronwyn Mixter (B)

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-5277-4399

Kirsten B Goldberg (KB)

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-8659-1240

Paul Kluetz (P)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-9796-4791

Richard Pazdur (R)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-4771-9923

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Highlights of FDA Oncology Approvals in 2022:...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Épidémies de maladies › Épidémies › Pandémies › Highlights of FDA Oncology Approvals in 2022:...
questionsmedicales.fr › Professions de santé › Médecine › Médecine interne › Oncologie médicale › Highlights of FDA Oncology Approvals in 2022:...
questionsmedicales.fr › Techniques d'investigation › Développement de médicament › Highlights of FDA Oncology Approvals in 2022:...
questionsmedicales.fr › Sciences sociales › Sociologie › Agrément de médicaments › Highlights of FDA Oncology Approvals in 2022:...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Traitements médicamenteux de la COVID-19 › Highlights of FDA Oncology Approvals in 2022:...