FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Breast Neoplasms
/ drug therapy
Class I Phosphatidylinositol 3-Kinases
/ genetics
Double-Blind Method
Drug Approval
Female
Fulvestrant
/ administration & dosage
Humans
Male
Middle Aged
Mutation
Neoplasm Metastasis
Patient Reported Outcome Measures
Receptor, ErbB-2
/ analysis
Receptors, Estrogen
/ analysis
Thiazoles
/ administration & dosage
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 04 2021
01 04 2021
Historique:
received:
16
09
2020
revised:
19
10
2020
accepted:
05
11
2020
pubmed:
11
11
2020
medline:
11
3
2022
entrez:
10
11
2020
Statut:
ppublish
Résumé
On May 24, 2019, the FDA granted regular approval to alpelisib in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, HER2-negative, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Approval was based on the SOLAR-1 study, a randomized, double-blind, placebo-controlled trial of alpelisib plus fulvestrant versus placebo plus fulvestrant. The primary endpoint was investigator-assessed progression-free survival (PFS) per RECIST v1.1 in the cohort of trial participants whose tumors had a PIK3CA mutation. The estimated median PFS by investigator assessment in the alpelisib plus fulvestrant arm was 11 months [95% confidence interval (CI), 7.5-14.5] compared with 5.7 months (95% CI, 3.7-7.4) in the placebo plus fulvestrant arm (HR, 0.65; 95% CI, 0.50-0.85; two-sided
Identifiants
pubmed: 33168657
pii: 1078-0432.CCR-20-3652
doi: 10.1158/1078-0432.CCR-20-3652
pmc: PMC8535764
mid: NIHMS1644537
doi:
Substances chimiques
Receptors, Estrogen
0
Thiazoles
0
Alpelisib
08W5N2C97Q
Fulvestrant
22X328QOC4
Class I Phosphatidylinositol 3-Kinases
EC 2.7.1.137
PIK3CA protein, human
EC 2.7.1.137
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1842-1849Subventions
Organisme : Intramural FDA HHS
ID : FD999999
Pays : United States
Informations de copyright
©2020 American Association for Cancer Research.
Références
Ann Oncol. 2020 Mar;31(3):377-386
pubmed: 32067679
N Engl J Med. 2017 Nov 9;377(19):1836-1846
pubmed: 29117498
Clin Cancer Res. 2021 Jan 1;27(1):11-14
pubmed: 32816899
Mol Cancer Ther. 2018 May;17(5):908-920
pubmed: 29483206
Cancer Cell. 2014 Jul 14;26(1):136-49
pubmed: 25002028