US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative,

Journal

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333

Informations de publication

Date de publication:
21 Feb 2024
Historique:
medline: 21 2 2024
pubmed: 21 2 2024
entrez: 21 2 2024
Statut: aheadofprint

Résumé

The US Food and Drug Administration (FDA) approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 ( Approval was based on EMERALD (Study RAD1901-308), a randomized, open-label, active-controlled, multicenter trial in 478 patients with ER+, HER2- advanced or metastatic breast cancer, including 228 patients with In the The approval of elacestrant in ER+, HER2- advanced or metastatic breast cancer was restricted to patients with

Identifiants

DOI: 10.1200/JCO.23.02112 PMID: 38381994
pubmed: 38381994
doi: 10.1200/JCO.23.02112
doi:

Banques de données

ClinicalTrials.gov
['NCT03778931']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

JCO2302112

Auteurs

Mirat Shah (M)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0003-0052-9978

Hima Lingam (H)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0009-0003-6214-7921

Xin Gao (X)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-7383-6453

Haley Gittleman (H)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-6976-8777

Mallorie H Fiero (MH)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Danielle Krol (D)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-2172-9680

Nikolett Biel (N)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Tiffany K Ricks (TK)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Wentao Fu (W)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Salaheldin Hamed (S)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Fang Li (F)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Jillian Jielin Sun (JJ)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Jianghong Fan (J)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Robert Schuck (R)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-5855-1361

Manuela Grimstein (M)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-6430-3022

Liuya Tang (L)

Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.

Shyam Kalavar (S)

Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.

Abdelrahmman Abukhdeir (A)

Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.

Anand Pathak (A)

Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.

Soma Ghosh (S)

Center for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.

Ilynn Bulatao (I)

Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-4706-0372

Amy Tilley (A)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

William F Pierce (WF)

Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-3411-7720

Bronwyn D Mixter (BD)

Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0001-5277-4399

Shenghui Tang (S)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-0437-665X

Richard Pazdur (R)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-4771-9923

Paul Kluetz (P)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.

Laleh Amiri-Kordestani (L)

Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.
ORCID: 0000-0002-0056-5437

Classifications MeSH