U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review.
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
15 03 2022
15 03 2022
Historique:
received:
04
08
2021
revised:
01
10
2021
accepted:
19
10
2021
pubmed:
30
10
2021
medline:
16
4
2022
entrez:
29
10
2021
Statut:
ppublish
Résumé
Over the last decade, there has been tremendous progress in the treatment of patients with gynecologic cancers with a changing therapy landscape. This summary provides an overview of U.S. Food and Drug Administration (FDA) approvals for gynecologic cancers from 2010 to 2020, totaling 17 new indications. For each of the approved indications, endpoints, trial design, results, and regulatory considerations are outlined. Among these 17 indications, six received accelerated approval (AA) and 11 received regular approval (RA). As of September 2021, of the six AA, three have subsequently demonstrated clinical benefit resulting in conversion to RA and the remaining three have ongoing clinical trials that have not yet reported results. Approval decisions for these 17 indications were supported by primary efficacy endpoints of progression-free survival (n = 10), objective response rate (n = 6), and overall survival (n = 1) and showed a favorable benefit-risk profile. Among the 17 indications, 15 received priority review and three applications participated in one or more novel Oncology Center of Excellence initiatives, including Real Time Oncology Review, Assessment Aid, and Project Orbis. Current FDA thinking on drug development opportunities and regulatory initiatives currently under way will be discussed.
Identifiants
pubmed: 34711631
pii: 1078-0432.CCR-21-2599
doi: 10.1158/1078-0432.CCR-21-2599
pmc: PMC8923904
mid: NIHMS1750393
doi:
Substances chimiques
Antineoplastic Agents
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1058-1071Subventions
Organisme : Intramural FDA HHS
ID : FD999999
Pays : United States
Informations de copyright
©2021 American Association for Cancer Research.
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