FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome.
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ therapeutic use
Drug Approval
Drug Resistance, Neoplasm
Histone Deacetylase Inhibitors
/ therapeutic use
Humans
Middle Aged
Mycosis Fungoides
/ drug therapy
Neoplasm Recurrence, Local
/ drug therapy
Progression-Free Survival
Receptors, CCR4
/ metabolism
Salvage Therapy
Sezary Syndrome
/ drug therapy
Skin Neoplasms
/ drug therapy
Survival Rate
United States
United States Food and Drug Administration
Vorinostat
/ therapeutic use
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 12 2019
15 12 2019
Historique:
received:
20
06
2019
revised:
19
07
2019
accepted:
26
07
2019
pubmed:
2
8
2019
medline:
27
10
2020
entrez:
2
8
2019
Statut:
ppublish
Résumé
The FDA-approved mogamulizumab-kpkc, a CC chemokine receptor type 4 (CCR4)-directed mAb, in August 2018 for treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Regular approval was based on a randomized, open-label trial that randomized 372 such patients, with a median of 3 prior systemic therapies, to either mogamulizumab-kpkc or vorinostat. Investigator-assessed progression-free survival (PFS) was statistically significantly longer in the mogamulizumab-kpkc arm, which had an estimated median PFS of 7.6 months [95% confidence interval (CI), 5.6-10.2] compared with 3.1 months (95% CI, 2.8-4.0) in the vorinostat arm (HR = 0.53; 95% CI, 0.41-0.69). The confirmed overall response rate was 28% and 5%, respectively (
Identifiants
pubmed: 31366601
pii: 1078-0432.CCR-19-2030
doi: 10.1158/1078-0432.CCR-19-2030
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Histone Deacetylase Inhibitors
0
Receptors, CCR4
0
Vorinostat
58IFB293JI
mogamulizumab
YI437801BE
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
7275-7280Commentaires et corrections
Type : CommentIn
Informations de copyright
©2019 American Association for Cancer Research.