FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer.
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 08 2020
15 08 2020
Historique:
received:
19
12
2019
revised:
14
02
2020
accepted:
23
03
2020
pubmed:
29
3
2020
medline:
28
10
2021
entrez:
29
3
2020
Statut:
ppublish
Résumé
On May 3, 2019, the FDA granted regular approval to ado-trastuzumab emtansine (KADCYLA), for the adjuvant treatment of patients with HER2-positive early-breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane-based chemotherapy and trastuzumab-based treatment. Approval was based on data from the KATHERINE trial, which randomized patients to receive ado-trastuzumab emtansine or trastuzumab. At 3 years, the event-free rate for invasive disease-free survival in the ado-trastuzumab emtansine arm was 88.3% [95% confidence interval (CI), 85.8-90.7] compared with 77.0% (95% CI, 73.8-80.7) in the trastuzumab arm, (HR, 0.50; 95% CI, 0.39-0.64;
Identifiants
pubmed: 32217612
pii: 1078-0432.CCR-19-3980
doi: 10.1158/1078-0432.CCR-19-3980
doi:
Substances chimiques
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
Ado-Trastuzumab Emtansine
SE2KH7T06F
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
4180-4185Informations de copyright
©2020 American Association for Cancer Research.