FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma.
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ therapeutic use
Antineoplastic Agents, Immunological
/ therapeutic use
Colorectal Neoplasms
/ drug therapy
DNA Mismatch Repair
Drug Approval
Female
Humans
Male
Microsatellite Instability
Middle Aged
Neoplasm Staging
United States
Young Adult
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:
01 09 2021
01 09 2021
Historique:
received:
10
02
2021
revised:
19
03
2021
accepted:
26
03
2021
pubmed:
14
4
2021
medline:
5
4
2022
entrez:
13
4
2021
Statut:
ppublish
Résumé
The FDA approved pembrolizumab on June 29, 2020, for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) colorectal cancer with no prior systemic treatment for advanced disease. The approval was based on data from Study Keynote-177, which randomly allocated patients to receive either pembrolizumab or standard of care (SOC) with chemotherapy. Overall survival (OS) and independently assessed progression-free survival (PFS) were the primary endpoints. At the time of the final PFS analysis and second prespecified interim OS analysis, the estimated median PFS was 16.5 months (95% CI: 5.4-32.4) versus 8.2 months (95% CI: 6.1-10.2) in the pembrolizumab and SOC arms, respectively [HR: 0.60 (95% CI: 0.45-0.80); two-sided
Identifiants
pubmed: 33846198
pii: 1078-0432.CCR-21-0557
doi: 10.1158/1078-0432.CCR-21-0557
pmc: PMC8416693
mid: NIHMS1688760
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antineoplastic Agents, Immunological
0
pembrolizumab
DPT0O3T46P
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
4680-4684Subventions
Organisme : Intramural FDA HHS
ID : FD999999
Pays : United States
Informations de copyright
©2021 American Association for Cancer Research.
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